Federal Executive Branch
Here's a look at documents from the U.S. Executive Branch
Federal Agencies
Featured Stories
Justice Department to Conduct Election Monitoring in Florida and Wyoming Primary Elections
WASHINGTON, Aug. 19 -- The U.S. Department of Justice issued the following news release on Aug. 18, 2026:
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Justice Department to Conduct Election Monitoring in Florida and Wyoming Primary Elections
Today, the Civil Rights Division is monitoring polling sites in Florida and Wyoming for the states' primary elections to ensure transparency, ballot security, and compliance with federal law.
"Election monitoring is an ongoing priority for this office," said Assistant Attorney General Harmeet K. Dhillon of the Justice Department's Civil Rights Division. "Nondiscriminatory monitoring ensures ... Show Full Article WASHINGTON, Aug. 19 -- The U.S. Department of Justice issued the following news release on Aug. 18, 2026: * * * Justice Department to Conduct Election Monitoring in Florida and Wyoming Primary Elections Today, the Civil Rights Division is monitoring polling sites in Florida and Wyoming for the states' primary elections to ensure transparency, ballot security, and compliance with federal law. "Election monitoring is an ongoing priority for this office," said Assistant Attorney General Harmeet K. Dhillon of the Justice Department's Civil Rights Division. "Nondiscriminatory monitoring ensuresall elections remain free, fair, and accessible to all."
The DOJ, through the Civil Rights Division, enforces federal voting laws which protect the voting rights of all eligible citizens. The DOJ regularly deploys staff to monitor compliance with federal civil rights laws in communities across the country, as it previously did in Florida and Wyoming in 2022.
The DOJ is monitoring polls in Miami-Dade County, Florida, with approximately four Civil Rights Division attorneys and in Laramie County, Wyoming, with two Civil Rights Division attorneys. Thus far the DOJ has deployed over 75 monitors across five states and over 200 polling locations this primary season. By comparison, during the 2022 midterms the DOJ sent monitors to nine states.
This monitoring initiative is aimed at promoting transparency and an open flow of communication between poll observers and election monitors. The Civil Rights Division's Voting Section enforces various federal statutes that protect the right to vote, including the Voting Rights Act, National Voter Registration Act, Help America Vote Act, Uniformed and Overseas Citizens Absentee Voting Act, the Americans with Disabilities Act, and the Civil Rights Acts.
From now through the general election on Nov. 3, Civil Rights Division personnel will be available to receive questions and complaints from the public related to federal voting rights laws. If you have a question or complaint or would like to request election monitoring in a particular jurisdiction, please contact the Voting Section at VEM@usdoj.gov.
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Original text here: https://www.justice.gov/opa/pr/justice-department-conduct-election-monitoring-florida-and-wyoming-primary-elections
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Justice Department to Conduct Election Monitoring in Florida and Wyoming Primary Elections
Today, the Civil Rights Division is monitoring polling sites in Florida and Wyoming for the states' primary elections to ensure transparency, ballot security, and compliance with federal law.
"Election monitoring is an ongoing priority for this office," said Assistant Attorney General Harmeet K. Dhillon of the Justice Department's Civil Rights Division. "Nondiscriminatory monitoring ensures ... Show Full Article WASHINGTON, Aug. 19 -- The U.S. Department of Justice issued the following news release on Aug. 18, 2026: * * * Justice Department to Conduct Election Monitoring in Florida and Wyoming Primary Elections Today, the Civil Rights Division is monitoring polling sites in Florida and Wyoming for the states' primary elections to ensure transparency, ballot security, and compliance with federal law. "Election monitoring is an ongoing priority for this office," said Assistant Attorney General Harmeet K. Dhillon of the Justice Department's Civil Rights Division. "Nondiscriminatory monitoring ensuresall elections remain free, fair, and accessible to all."
The DOJ, through the Civil Rights Division, enforces federal voting laws which protect the voting rights of all eligible citizens. The DOJ regularly deploys staff to monitor compliance with federal civil rights laws in communities across the country, as it previously did in Florida and Wyoming in 2022.
The DOJ is monitoring polls in Miami-Dade County, Florida, with approximately four Civil Rights Division attorneys and in Laramie County, Wyoming, with two Civil Rights Division attorneys. Thus far the DOJ has deployed over 75 monitors across five states and over 200 polling locations this primary season. By comparison, during the 2022 midterms the DOJ sent monitors to nine states.
This monitoring initiative is aimed at promoting transparency and an open flow of communication between poll observers and election monitors. The Civil Rights Division's Voting Section enforces various federal statutes that protect the right to vote, including the Voting Rights Act, National Voter Registration Act, Help America Vote Act, Uniformed and Overseas Citizens Absentee Voting Act, the Americans with Disabilities Act, and the Civil Rights Acts.
From now through the general election on Nov. 3, Civil Rights Division personnel will be available to receive questions and complaints from the public related to federal voting rights laws. If you have a question or complaint or would like to request election monitoring in a particular jurisdiction, please contact the Voting Section at VEM@usdoj.gov.
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Original text here: https://www.justice.gov/opa/pr/justice-department-conduct-election-monitoring-florida-and-wyoming-primary-elections
IDB Report: Caribbean Economies Made Notable Progress in Debt Reduction and Fiscal Sustainability
WASHINGTON, Aug. 19 (TNSbrep) -- The Inter-American Development Bank issued the following news release:
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IDB Report: Caribbean Economies Made Notable Progress in Debt Reduction and Fiscal Sustainability
Caribbean Economics Quarterly highlights public finance, and tax reforms drive faster, more resilient, and sustainable long-term growth.
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Caribbean economies have achieved notable fiscal consolidation and debt reduction despite the persistence of high global interest rates and volatile energy markets, according to a new Inter-American Development Bank (IDB) report.
The new edition ... Show Full Article WASHINGTON, Aug. 19 (TNSbrep) -- The Inter-American Development Bank issued the following news release: * * * IDB Report: Caribbean Economies Made Notable Progress in Debt Reduction and Fiscal Sustainability Caribbean Economics Quarterly highlights public finance, and tax reforms drive faster, more resilient, and sustainable long-term growth. - Caribbean economies have achieved notable fiscal consolidation and debt reduction despite the persistence of high global interest rates and volatile energy markets, according to a new Inter-American Development Bank (IDB) report. The new editionof the Caribbean Economics Quarterly (CEQ), titled "Fiscal Resilience, Debt Reduction and Domestic Resource Mobilization in the Caribbean," examines the fiscal and debt trajectories of six member countries of the IDB's Caribbean Country Department: The Bahamas, Barbados, Guyana, Jamaica, Suriname, and Trinidad and Tobago. It finds that half of these countries have successfully reduced their debt-to-GDP ratios below pre-pandemic levels, demonstrating the effectiveness of disciplined fiscal management and credible institutional frameworks.
However, the CEQ warns that the regional fiscal environment remains challenged due to tighter global financial conditions rather than a deterioration in investor perceptions of the Caribbean.
"Caribbean nations have navigated an extraordinarily complex series of global shocks in the recent decade with impressive policy discipline," said Anton Edmunds, IDB General Manager for the Caribbean.
"The data shows that substantial debt reduction is possible when governments maintain credible fiscal frameworks. Moving forward, the priority must be building more productive, fair, and resilient revenue systems that can finance both debt reduction and critical investments, including in disaster risk management," he added
A central finding of the report is that the region collects less revenue than it needs for sustainable development and disaster resilience. Tax revenues in the Caribbean averaged 21 percent of GDP in 2023, below the Latin American average of 22 percent and the Organization for Economic Co-operation and Development (OECD) average of 34 percent.
The CEQ highlights several cross-country reform priorities to address this gap, including modernizing tax administration through digital technologies, rationalizing tax incentives and exemptions, and strengthening stable revenue sources such as property taxation. For oil and gas producers, the report stresses the importance of strong fiscal rules and sovereign wealth funds to smooth revenue volatility and preserve wealth for future generations.
The full Caribbean Economics Quarterly report is available for reading on the IDB website (https://publications.iadb.org/en/caribbean-economics-quarterly-volume-16-issue-2-fiscal-resilience-debt-reduction-and-domestic).
The Caribbean Economics Quarterly publication series is a trusted resource for policymakers, academia, and businesses. Previous editions are available here (https://publications.iadb.org/en?keys=Caribbean+Economics+Quarterly).
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About the IDB
The Inter-American Development Bank (IDB), a member of the IDB Group, is devoted to improving lives across Latin America and the Caribbean. Founded in 1959, the Bank works with the region's public sector to design and enable impactful, innovative solutions for sustainable and inclusive development. Leveraging financing, technical expertise, and knowledge, it promotes growth and well-being in 26 countries. Visit our website: www.iadb.org/en.
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Original text here: https://www.iadb.org/en/news/idb-report-caribbean-economies-made-notable-progress-debt-reduction-and-fiscal-sustainability
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IDB Report: Caribbean Economies Made Notable Progress in Debt Reduction and Fiscal Sustainability
Caribbean Economics Quarterly highlights public finance, and tax reforms drive faster, more resilient, and sustainable long-term growth.
-
Caribbean economies have achieved notable fiscal consolidation and debt reduction despite the persistence of high global interest rates and volatile energy markets, according to a new Inter-American Development Bank (IDB) report.
The new edition ... Show Full Article WASHINGTON, Aug. 19 (TNSbrep) -- The Inter-American Development Bank issued the following news release: * * * IDB Report: Caribbean Economies Made Notable Progress in Debt Reduction and Fiscal Sustainability Caribbean Economics Quarterly highlights public finance, and tax reforms drive faster, more resilient, and sustainable long-term growth. - Caribbean economies have achieved notable fiscal consolidation and debt reduction despite the persistence of high global interest rates and volatile energy markets, according to a new Inter-American Development Bank (IDB) report. The new editionof the Caribbean Economics Quarterly (CEQ), titled "Fiscal Resilience, Debt Reduction and Domestic Resource Mobilization in the Caribbean," examines the fiscal and debt trajectories of six member countries of the IDB's Caribbean Country Department: The Bahamas, Barbados, Guyana, Jamaica, Suriname, and Trinidad and Tobago. It finds that half of these countries have successfully reduced their debt-to-GDP ratios below pre-pandemic levels, demonstrating the effectiveness of disciplined fiscal management and credible institutional frameworks.
However, the CEQ warns that the regional fiscal environment remains challenged due to tighter global financial conditions rather than a deterioration in investor perceptions of the Caribbean.
"Caribbean nations have navigated an extraordinarily complex series of global shocks in the recent decade with impressive policy discipline," said Anton Edmunds, IDB General Manager for the Caribbean.
"The data shows that substantial debt reduction is possible when governments maintain credible fiscal frameworks. Moving forward, the priority must be building more productive, fair, and resilient revenue systems that can finance both debt reduction and critical investments, including in disaster risk management," he added
A central finding of the report is that the region collects less revenue than it needs for sustainable development and disaster resilience. Tax revenues in the Caribbean averaged 21 percent of GDP in 2023, below the Latin American average of 22 percent and the Organization for Economic Co-operation and Development (OECD) average of 34 percent.
The CEQ highlights several cross-country reform priorities to address this gap, including modernizing tax administration through digital technologies, rationalizing tax incentives and exemptions, and strengthening stable revenue sources such as property taxation. For oil and gas producers, the report stresses the importance of strong fiscal rules and sovereign wealth funds to smooth revenue volatility and preserve wealth for future generations.
The full Caribbean Economics Quarterly report is available for reading on the IDB website (https://publications.iadb.org/en/caribbean-economics-quarterly-volume-16-issue-2-fiscal-resilience-debt-reduction-and-domestic).
The Caribbean Economics Quarterly publication series is a trusted resource for policymakers, academia, and businesses. Previous editions are available here (https://publications.iadb.org/en?keys=Caribbean+Economics+Quarterly).
* * *
About the IDB
The Inter-American Development Bank (IDB), a member of the IDB Group, is devoted to improving lives across Latin America and the Caribbean. Founded in 1959, the Bank works with the region's public sector to design and enable impactful, innovative solutions for sustainable and inclusive development. Leveraging financing, technical expertise, and knowledge, it promotes growth and well-being in 26 countries. Visit our website: www.iadb.org/en.
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Original text here: https://www.iadb.org/en/news/idb-report-caribbean-economies-made-notable-progress-debt-reduction-and-fiscal-sustainability
HHS Announces New Peer Support Prevention Services to Strengthen Families, Advancing the Great American Recovery and A Home for Every Child Initiatives
WASHINGTON, Aug. 19 -- The U.S. Department of Health and Human Services Administration for Children and Families issued the following news release on Aug. 18, 2026:
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HHS Announces New Peer Support Prevention Services to Strengthen Families, Advancing the Great American Recovery and A Home for Every Child Initiatives
The U.S. Department of Health and Human Services (HHS) through the Administration for Children and Families (ACF) today added new peer support programs to the Title-IV Prevention Services Clearinghouse, for which all states can now claim federal reimbursement. The expansion ... Show Full Article WASHINGTON, Aug. 19 -- The U.S. Department of Health and Human Services Administration for Children and Families issued the following news release on Aug. 18, 2026: * * * HHS Announces New Peer Support Prevention Services to Strengthen Families, Advancing the Great American Recovery and A Home for Every Child Initiatives The U.S. Department of Health and Human Services (HHS) through the Administration for Children and Families (ACF) today added new peer support programs to the Title-IV Prevention Services Clearinghouse, for which all states can now claim federal reimbursement. The expansionadvances the Trump Administration's Great American Recovery and A Home for Every Child initiatives by equipping states with evidence-based resources to help parents overcome addiction, thereby strengthening families and reducing the number of children entering foster care.
HHS Secretary Robert F. Kennedy Jr., White House Senior Advisor for Addiction Recovery and Co-Chair of the Great American Recovery Initiative Kathryn Burgum, and ACF Assistant Secretary Alex J. Adams joined Governor Kim Reynolds in Des Moines to make the announcement.
"Addiction tears families apart. Recovery brings parents home and keeps children with the families who love them," said HHS Secretary Robert F. Kennedy, Jr. "Under President Trump's Great American Recovery, we are expanding proven peer support that helps parents overcome addiction, strengthens families, and keeps children out of foster care."
"Iowa is proud to be first in the nation to adopt new peer-support interventions," said Iowa Governor Kim Reynolds. "By responding to addiction and supporting struggling families, we're building a stronger America: one where recovery is real, every child has a home, and hope is never out of reach for anyone."
Iowa is the first state to adopt one of the new programs that feature peer support interventions, having already updated its state prevention plan with ACF's pre-reviewed model language to include these evidence-based approaches that help families affected by the chronic disease of addiction.
In January 2026, President Donald Trump launched the Great American Recovery to help struggling Americans find treatment faster, stay connected to recovery support, and rebuild their lives with dignity, purpose, and community through a coordinated, evidence-based approach.
"Peer support specialists are living proof that recovery is possible. Their lived experience is a powerful source of hope, connection and guidance for families working to overcome the chronic disease of addiction," said White House Senior Advisor for Addiction Recovery and Co-Chair of the Great American Recovery Kathryn Burgum. "Peer support is a high priority for the Great American Recovery because it remains one of the biggest gaps in our recovery system. Iowa is the first state to take this important step, expanding access to these services to help parents and strengthen families. We encourage states across the country to follow Iowa's lead as we advance President Trump's vision for a recovery system that leaves no American behind."
ACF's A Home for Every Child aims to improve the ratio of foster homes to the number of children in foster care. Prevention efforts anchor this initiative to help strengthen families and reduce foster care entries in the first place, which is why ACF continues to add new services to the Title IV-E Prevention Services Clearinghouse.
"Parental substance use disorder is a leading cause of child entry into foster care. The Trump Administration has already strengthened the suite of services available to both prevent and treat this disease, and today's action doubles down on evidence-based prevention by unlocking federal matching funds for proven programs that integrate peer support," said ACF Assistant Secretary Alex J. Adams.
ACF has determined that two new peer support interventions meet the evidence standards to be included in the Title IV-E Prevention Services Clearinghouse, enabling states to claim federal matching funds when delivering these services:
* Family-Based Recovery -- Supported. This is an intensive in-home clinical treatment to support parents of children ages 0-5 with the chronic disease of addiction and allows a parent to receive the help they need, including a weekly peer support meeting, while ensuring children develop in a safe, substance-free, and stable home with their parents.
* Wellness Recovery Action Plan (WRAP) -- Supported. WRAP is a facilitated peer group program, delivered by trained peer facilitators, designed to support individuals in the areas of mental health and the chronic disease of addiction. The program coaches individuals through recovery concepts and helps participants respond to and recover from crises.
Family-Based Recovery and WRAP join two other programs that feature peer support already included in the Clearinghouse with a Supported rating, Sobriety Treatment and Recovery Teams (START) and Parents Anonymous .
"Addressing addiction requires more than treatment alone -- it requires investing in people, families, and the communities that support recovery," said Substance Abuse and Mental Health Services Administration Chief of Staff Tim Westlake. "Moving from a pill culture to a purpose culture means recognizing that recovery is strengthened through relationships, belonging, meaning, and purpose. Providing new federal funding pathways for evidence-based peer support puts that principle into practice, connecting individuals and families with people who understand the journey of recovery and can offer hope, encouragement, and the support."
Now that Family-Based Recovery and WRAP have been added to the Clearinghouse, other states now have an opportunity to follow Iowa's lead and update their state prevention plans to claim federal reimbursement for peer support interventions. Today, ACF's Office of Planning, Research, and Evaluation (OPRE) also issued a public call for additional recommendations for peer support programs and services that can be systematically reviewed for future inclusion in the Clearinghouse.
Today's announcements are HHS' latest actions to advance the Great American Recovery. Learn more here (https://www.hhs.gov/recovery/index.html).
* * *
Quotes
Addiction tears families apart. Recovery brings parents home and keeps children with the families who love them. Under President Trump's Great American Recovery, we are expanding proven peer support that helps parents overcome addiction, strengthens families, and keeps children out of foster care.
-- HHS Secretary Robert F. Kennedy, Jr.
* * *
Iowa is proud to be first in the nation to adopt new peer-support interventions. By responding to addiction and supporting struggling families, we're building a stronger America: one where recovery is real, every child has a home, and hope is never out of reach for anyone.
-- Iowa Governor Kim Reynolds
* * *
Peer support specialists are living proof that recovery is possible. Their lived experience is a powerful source of hope, connection and guidance for families working to overcome the chronic disease of addiction. Peer support is a high priority for the Great American Recovery because it remains one of the biggest gaps in our recovery system. Iowa is the first state to take this important step, expanding access to these services to help parents and strengthen families. We encourage states across the country to follow Iowa's lead as we advance President Trump's vision for a recovery system that leaves no American behind.
-- White House Senior Advisor for Addiction Recovery and Co-Chair of the Great American Recovery Kathryn Burgum
* * *
Parental substance use disorder is a leading cause of child entry into foster care. The Trump Administration has already strengthened the suite of services available to both prevent and treat this disease, and today's action doubles down on evidence-based prevention by unlocking federal matching funds for proven programs that integrate peer support.
-- ACF Assistant Secretary Alex J. Adams
* * *
Addressing addiction requires more than treatment alone--it requires investing in people, families, and the communities that support recovery. Moving from a pill culture to a purpose culture means recognizing that recovery is strengthened through relationships, belonging, meaning, and purpose. Providing new federal funding pathways for evidence-based peer support puts that principle into practice, connecting individuals and families with people who understand the journey of recovery and can offer hope, encouragement, and the support.
-- Substance Abuse and Mental Health Services Administration Chief of Staff Tim Westlake
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Original text here: https://acf.gov/media/press/2026/hhs-announces-new-peer-support-prevention-services-strengthen-families-advancing
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HHS Announces New Peer Support Prevention Services to Strengthen Families, Advancing the Great American Recovery and A Home for Every Child Initiatives
The U.S. Department of Health and Human Services (HHS) through the Administration for Children and Families (ACF) today added new peer support programs to the Title-IV Prevention Services Clearinghouse, for which all states can now claim federal reimbursement. The expansion ... Show Full Article WASHINGTON, Aug. 19 -- The U.S. Department of Health and Human Services Administration for Children and Families issued the following news release on Aug. 18, 2026: * * * HHS Announces New Peer Support Prevention Services to Strengthen Families, Advancing the Great American Recovery and A Home for Every Child Initiatives The U.S. Department of Health and Human Services (HHS) through the Administration for Children and Families (ACF) today added new peer support programs to the Title-IV Prevention Services Clearinghouse, for which all states can now claim federal reimbursement. The expansionadvances the Trump Administration's Great American Recovery and A Home for Every Child initiatives by equipping states with evidence-based resources to help parents overcome addiction, thereby strengthening families and reducing the number of children entering foster care.
HHS Secretary Robert F. Kennedy Jr., White House Senior Advisor for Addiction Recovery and Co-Chair of the Great American Recovery Initiative Kathryn Burgum, and ACF Assistant Secretary Alex J. Adams joined Governor Kim Reynolds in Des Moines to make the announcement.
"Addiction tears families apart. Recovery brings parents home and keeps children with the families who love them," said HHS Secretary Robert F. Kennedy, Jr. "Under President Trump's Great American Recovery, we are expanding proven peer support that helps parents overcome addiction, strengthens families, and keeps children out of foster care."
"Iowa is proud to be first in the nation to adopt new peer-support interventions," said Iowa Governor Kim Reynolds. "By responding to addiction and supporting struggling families, we're building a stronger America: one where recovery is real, every child has a home, and hope is never out of reach for anyone."
Iowa is the first state to adopt one of the new programs that feature peer support interventions, having already updated its state prevention plan with ACF's pre-reviewed model language to include these evidence-based approaches that help families affected by the chronic disease of addiction.
In January 2026, President Donald Trump launched the Great American Recovery to help struggling Americans find treatment faster, stay connected to recovery support, and rebuild their lives with dignity, purpose, and community through a coordinated, evidence-based approach.
"Peer support specialists are living proof that recovery is possible. Their lived experience is a powerful source of hope, connection and guidance for families working to overcome the chronic disease of addiction," said White House Senior Advisor for Addiction Recovery and Co-Chair of the Great American Recovery Kathryn Burgum. "Peer support is a high priority for the Great American Recovery because it remains one of the biggest gaps in our recovery system. Iowa is the first state to take this important step, expanding access to these services to help parents and strengthen families. We encourage states across the country to follow Iowa's lead as we advance President Trump's vision for a recovery system that leaves no American behind."
ACF's A Home for Every Child aims to improve the ratio of foster homes to the number of children in foster care. Prevention efforts anchor this initiative to help strengthen families and reduce foster care entries in the first place, which is why ACF continues to add new services to the Title IV-E Prevention Services Clearinghouse.
"Parental substance use disorder is a leading cause of child entry into foster care. The Trump Administration has already strengthened the suite of services available to both prevent and treat this disease, and today's action doubles down on evidence-based prevention by unlocking federal matching funds for proven programs that integrate peer support," said ACF Assistant Secretary Alex J. Adams.
ACF has determined that two new peer support interventions meet the evidence standards to be included in the Title IV-E Prevention Services Clearinghouse, enabling states to claim federal matching funds when delivering these services:
* Family-Based Recovery -- Supported. This is an intensive in-home clinical treatment to support parents of children ages 0-5 with the chronic disease of addiction and allows a parent to receive the help they need, including a weekly peer support meeting, while ensuring children develop in a safe, substance-free, and stable home with their parents.
* Wellness Recovery Action Plan (WRAP) -- Supported. WRAP is a facilitated peer group program, delivered by trained peer facilitators, designed to support individuals in the areas of mental health and the chronic disease of addiction. The program coaches individuals through recovery concepts and helps participants respond to and recover from crises.
Family-Based Recovery and WRAP join two other programs that feature peer support already included in the Clearinghouse with a Supported rating, Sobriety Treatment and Recovery Teams (START) and Parents Anonymous .
"Addressing addiction requires more than treatment alone -- it requires investing in people, families, and the communities that support recovery," said Substance Abuse and Mental Health Services Administration Chief of Staff Tim Westlake. "Moving from a pill culture to a purpose culture means recognizing that recovery is strengthened through relationships, belonging, meaning, and purpose. Providing new federal funding pathways for evidence-based peer support puts that principle into practice, connecting individuals and families with people who understand the journey of recovery and can offer hope, encouragement, and the support."
Now that Family-Based Recovery and WRAP have been added to the Clearinghouse, other states now have an opportunity to follow Iowa's lead and update their state prevention plans to claim federal reimbursement for peer support interventions. Today, ACF's Office of Planning, Research, and Evaluation (OPRE) also issued a public call for additional recommendations for peer support programs and services that can be systematically reviewed for future inclusion in the Clearinghouse.
Today's announcements are HHS' latest actions to advance the Great American Recovery. Learn more here (https://www.hhs.gov/recovery/index.html).
* * *
Quotes
Addiction tears families apart. Recovery brings parents home and keeps children with the families who love them. Under President Trump's Great American Recovery, we are expanding proven peer support that helps parents overcome addiction, strengthens families, and keeps children out of foster care.
-- HHS Secretary Robert F. Kennedy, Jr.
* * *
Iowa is proud to be first in the nation to adopt new peer-support interventions. By responding to addiction and supporting struggling families, we're building a stronger America: one where recovery is real, every child has a home, and hope is never out of reach for anyone.
-- Iowa Governor Kim Reynolds
* * *
Peer support specialists are living proof that recovery is possible. Their lived experience is a powerful source of hope, connection and guidance for families working to overcome the chronic disease of addiction. Peer support is a high priority for the Great American Recovery because it remains one of the biggest gaps in our recovery system. Iowa is the first state to take this important step, expanding access to these services to help parents and strengthen families. We encourage states across the country to follow Iowa's lead as we advance President Trump's vision for a recovery system that leaves no American behind.
-- White House Senior Advisor for Addiction Recovery and Co-Chair of the Great American Recovery Kathryn Burgum
* * *
Parental substance use disorder is a leading cause of child entry into foster care. The Trump Administration has already strengthened the suite of services available to both prevent and treat this disease, and today's action doubles down on evidence-based prevention by unlocking federal matching funds for proven programs that integrate peer support.
-- ACF Assistant Secretary Alex J. Adams
* * *
Addressing addiction requires more than treatment alone--it requires investing in people, families, and the communities that support recovery. Moving from a pill culture to a purpose culture means recognizing that recovery is strengthened through relationships, belonging, meaning, and purpose. Providing new federal funding pathways for evidence-based peer support puts that principle into practice, connecting individuals and families with people who understand the journey of recovery and can offer hope, encouragement, and the support.
-- Substance Abuse and Mental Health Services Administration Chief of Staff Tim Westlake
* * *
Original text here: https://acf.gov/media/press/2026/hhs-announces-new-peer-support-prevention-services-strengthen-families-advancing
FDA Center for Tobacco Products Issues Warning Letter to Giantnic.com
WASHINGTON, Aug. 19 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to giantnic.com from its Center for Tobacco Products:
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Recipient: giantnic.com, 11528 Harry Hines Boulevard Suite B-213, Dallas, TX 75229, United States, sales@giantnic.com, giantnic@gmail.com, support@giantnic.com
Issuing Office: Center for Tobacco Products, United States
WARNING LETTER
To Whom It May Concern:
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website https://giantnic.com and determined ... Show Full Article WASHINGTON, Aug. 19 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to giantnic.com from its Center for Tobacco Products: * * * Recipient: giantnic.com, 11528 Harry Hines Boulevard Suite B-213, Dallas, TX 75229, United States, sales@giantnic.com, giantnic@gmail.com, support@giantnic.com Issuing Office: Center for Tobacco Products, United States WARNING LETTER To Whom It May Concern: The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website https://giantnic.com and determinedthat electronic nicotine delivery system (ENDS) products listed there are offered for sale or distribution to consumers in the United States.
Under section 201(rr) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. Sec. 321(rr)), these products are tobacco products because they are made or derived from tobacco or contain nicotine from any source, and are intended for human consumption./1 Certain tobacco products, including ENDS products, are subject to FDA jurisdiction under section 901 of the FD&C Act (21 U.S.C. Sec. 387a) and 21 C.F.R. Sec. 1100.1, and are required to be in compliance with the requirements in the FD&C Act. Under section 906(d)(5) of the FD&C Act (21 U.S.C. Sec. 387f(d)(5)), it is unlawful for any retailer/2 to sell a tobacco product to any person younger than 21 years of age./3 This includes tobacco products containing nicotine from any source including cigarettes, smokeless tobacco, cigars, e-cigarettes, and nicotine pouches.
Tobacco Product Sold by a Retailer to an Individual Under the Age of 21 is Misbranded
Under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. Sec. 387c(a)(7)(B)), tobacco products are misbranded if sold or distributed by any retailer to a person younger than 21 years of age in violation of section 906(d)(5) of the FD&C Act (21 U.S.C. Sec. 387f(d)(5)). FDA has determined that your Oxbar Astro Maze 50K Disposable Snickerdiddler ENDS product is misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. Sec. 387c(a)(7)(B)) because this product was sold to a person younger than 21 years of age. Specifically, during FDA's investigation of https://giantnic.com, a person younger than 21 years of age purchased Oxbar Astro Maze 50K Disposable Snickerdiddler ENDS product from your website.
Conclusion and Requested Actions
It is your responsibility to ensure that your tobacco products and all related labeling and/or advertising on this website, on any other websites (including e-commerce, social networking, or search engine websites), in any other media in which you advertise, and in any retail establishments comply with each applicable provision of the FD&C Act and FDA's implementing regulations. Failure to address any violations of the FD&C Act, 21 U.S.C. Sec. 301 et seq., and FDA's implementing regulations, including those in 21 C.F.R. Parts 1140, 1141, and 1143, may lead to regulatory action, including, but not limited to, civil money penalties, seizure, and/or injunction. Please note that tobacco products offered for import into the United States that appear to be adulterated or misbranded may be detained or refused admission.
Please be aware that the FD&C Act requires "new tobacco products" to have premarket authorization. A "new tobacco product" is any tobacco product that was not commercially marketed in the United States as of February 15, 2007, or any modified tobacco product that was commercially marketed after February 15, 2007. See Section 910(a) of the FD&C Act. For a list of all products that have been authorized by the FDA and certain others that may be legally marketed, please visit the Searchable Tobacco Products Database: https://www.fda.gov/searchtobacco.
You should take prompt action to address the violations that are referenced above, as well as any violations of the FD&C Act and FDA's implementing regulations that are the same as or similar to the ones stated above, and take any necessary actions to bring all your tobacco products into compliance with the FD&C Act.
Please submit a written response to this letter within 15 working days from the date of receipt describing your actions to address any violations and bring your products into compliance, including the dates on which you discontinued the violative labeling, advertising, sale, and/or distribution of these tobacco products and your plan for maintaining compliance with the FD&C Act. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. This letter notifies you of our findings and provides you with an opportunity to address them. You can find the FD&C Act through links on FDA's homepage at https://www.fda.gov.
Please note your reference number, RW2602438, in your response and direct your response via email at CTPCompliance@fda.hhs.gov and to the following address:
DPAL-WL Response, Office of Compliance and Enforcement FDA Center for Tobacco Products c/o Document Control Center Building 71, Room G335 10903 New Hampshire Avenue Silver Spring, MD 20993-0002
If you have any questions about the content of this letter, please contact CTPCompliance@fda.hhs.gov.
Sincerely,
/S/ Jill Atencio, Acting Director, Office of Compliance and Enforcement, Center for Tobacco Products
VIA UPS and Electronic Mail
cc: Giantnic, 11925 North Stemmons Freeway, Dallas, TX 75234
GoDaddy.com, LLC, abuse@godaddy.com
Shopify, Inc., abuse@shopify.com
* * *
Footnotes:
1/ Effective April 14, 2022, an amendment to the FD&C Act extends FDA's regulation of tobacco products to those containing nicotine from any source. For more information, please see, https://www.fda.gov/tobacco-products/ctp-newsroom/requirements-products-made-non-tobacco-nicotine-take-effect-april-14.
2/ The term 'retailer' means any person, government, or entity who sells tobacco products to individuals for personal consumption, or who operates a facility where self-service displays of tobacco products are permitted. Section 900(14) of the FD&C Act (21 U.S.C. Sec. 387(14)).
3/ Effective December 20, 2019, an amendment to the FD&C Act raises the minimum age of sale of tobacco products to age 21. For more information, please see https://www.fda.gov/tobacco-products/retail-sales-tobacco-products/tobacco-21.
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Original text here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/giantniccom-735905-08072026
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Recipient: giantnic.com, 11528 Harry Hines Boulevard Suite B-213, Dallas, TX 75229, United States, sales@giantnic.com, giantnic@gmail.com, support@giantnic.com
Issuing Office: Center for Tobacco Products, United States
WARNING LETTER
To Whom It May Concern:
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website https://giantnic.com and determined ... Show Full Article WASHINGTON, Aug. 19 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to giantnic.com from its Center for Tobacco Products: * * * Recipient: giantnic.com, 11528 Harry Hines Boulevard Suite B-213, Dallas, TX 75229, United States, sales@giantnic.com, giantnic@gmail.com, support@giantnic.com Issuing Office: Center for Tobacco Products, United States WARNING LETTER To Whom It May Concern: The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website https://giantnic.com and determinedthat electronic nicotine delivery system (ENDS) products listed there are offered for sale or distribution to consumers in the United States.
Under section 201(rr) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. Sec. 321(rr)), these products are tobacco products because they are made or derived from tobacco or contain nicotine from any source, and are intended for human consumption./1 Certain tobacco products, including ENDS products, are subject to FDA jurisdiction under section 901 of the FD&C Act (21 U.S.C. Sec. 387a) and 21 C.F.R. Sec. 1100.1, and are required to be in compliance with the requirements in the FD&C Act. Under section 906(d)(5) of the FD&C Act (21 U.S.C. Sec. 387f(d)(5)), it is unlawful for any retailer/2 to sell a tobacco product to any person younger than 21 years of age./3 This includes tobacco products containing nicotine from any source including cigarettes, smokeless tobacco, cigars, e-cigarettes, and nicotine pouches.
Tobacco Product Sold by a Retailer to an Individual Under the Age of 21 is Misbranded
Under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. Sec. 387c(a)(7)(B)), tobacco products are misbranded if sold or distributed by any retailer to a person younger than 21 years of age in violation of section 906(d)(5) of the FD&C Act (21 U.S.C. Sec. 387f(d)(5)). FDA has determined that your Oxbar Astro Maze 50K Disposable Snickerdiddler ENDS product is misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. Sec. 387c(a)(7)(B)) because this product was sold to a person younger than 21 years of age. Specifically, during FDA's investigation of https://giantnic.com, a person younger than 21 years of age purchased Oxbar Astro Maze 50K Disposable Snickerdiddler ENDS product from your website.
Conclusion and Requested Actions
It is your responsibility to ensure that your tobacco products and all related labeling and/or advertising on this website, on any other websites (including e-commerce, social networking, or search engine websites), in any other media in which you advertise, and in any retail establishments comply with each applicable provision of the FD&C Act and FDA's implementing regulations. Failure to address any violations of the FD&C Act, 21 U.S.C. Sec. 301 et seq., and FDA's implementing regulations, including those in 21 C.F.R. Parts 1140, 1141, and 1143, may lead to regulatory action, including, but not limited to, civil money penalties, seizure, and/or injunction. Please note that tobacco products offered for import into the United States that appear to be adulterated or misbranded may be detained or refused admission.
Please be aware that the FD&C Act requires "new tobacco products" to have premarket authorization. A "new tobacco product" is any tobacco product that was not commercially marketed in the United States as of February 15, 2007, or any modified tobacco product that was commercially marketed after February 15, 2007. See Section 910(a) of the FD&C Act. For a list of all products that have been authorized by the FDA and certain others that may be legally marketed, please visit the Searchable Tobacco Products Database: https://www.fda.gov/searchtobacco.
You should take prompt action to address the violations that are referenced above, as well as any violations of the FD&C Act and FDA's implementing regulations that are the same as or similar to the ones stated above, and take any necessary actions to bring all your tobacco products into compliance with the FD&C Act.
Please submit a written response to this letter within 15 working days from the date of receipt describing your actions to address any violations and bring your products into compliance, including the dates on which you discontinued the violative labeling, advertising, sale, and/or distribution of these tobacco products and your plan for maintaining compliance with the FD&C Act. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. This letter notifies you of our findings and provides you with an opportunity to address them. You can find the FD&C Act through links on FDA's homepage at https://www.fda.gov.
Please note your reference number, RW2602438, in your response and direct your response via email at CTPCompliance@fda.hhs.gov and to the following address:
DPAL-WL Response, Office of Compliance and Enforcement FDA Center for Tobacco Products c/o Document Control Center Building 71, Room G335 10903 New Hampshire Avenue Silver Spring, MD 20993-0002
If you have any questions about the content of this letter, please contact CTPCompliance@fda.hhs.gov.
Sincerely,
/S/ Jill Atencio, Acting Director, Office of Compliance and Enforcement, Center for Tobacco Products
VIA UPS and Electronic Mail
cc: Giantnic, 11925 North Stemmons Freeway, Dallas, TX 75234
GoDaddy.com, LLC, abuse@godaddy.com
Shopify, Inc., abuse@shopify.com
* * *
Footnotes:
1/ Effective April 14, 2022, an amendment to the FD&C Act extends FDA's regulation of tobacco products to those containing nicotine from any source. For more information, please see, https://www.fda.gov/tobacco-products/ctp-newsroom/requirements-products-made-non-tobacco-nicotine-take-effect-april-14.
2/ The term 'retailer' means any person, government, or entity who sells tobacco products to individuals for personal consumption, or who operates a facility where self-service displays of tobacco products are permitted. Section 900(14) of the FD&C Act (21 U.S.C. Sec. 387(14)).
3/ Effective December 20, 2019, an amendment to the FD&C Act raises the minimum age of sale of tobacco products to age 21. For more information, please see https://www.fda.gov/tobacco-products/retail-sales-tobacco-products/tobacco-21.
* * *
Original text here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/giantniccom-735905-08072026
FDA Center for Drug Evaluation & Research Issues Warning Letter to K.C. Pharmaceuticals
WASHINGTON, Aug. 19 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to K.C. Pharmaceuticals Inc. from its Center for Drug Evaluation and Research:
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Recipient: Ms. Ratnawati Li, Chief Executive Officer, K.C. Pharmaceuticals, Inc., 3420 Pomona Blvd., Pomona, CA 91768, United States
Issuing Office: Center for Drug Evaluation and Research (CDER), United States
Warning Letter 320-26-112
Dear Ms. Li:
The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, K.C. Pharmaceuticals, Inc., ... Show Full Article WASHINGTON, Aug. 19 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to K.C. Pharmaceuticals Inc. from its Center for Drug Evaluation and Research: * * * Recipient: Ms. Ratnawati Li, Chief Executive Officer, K.C. Pharmaceuticals, Inc., 3420 Pomona Blvd., Pomona, CA 91768, United States Issuing Office: Center for Drug Evaluation and Research (CDER), United States Warning Letter 320-26-112 Dear Ms. Li: The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, K.C. Pharmaceuticals, Inc.,FEI 2026940, at 3420 Pomona Blvd., Pomona, CA, from January 20 to February 13, 2026.
This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).
Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).
We reviewed your March 10, 2026, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.
During our inspection, our investigators observed specific violations including, but not limited to, the following.
1. Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)).
Media Fills
Your firm continued to manufacture and release sterile drug products manufactured by aseptic processing following media fill failures on June 21, 2024, September 4, 2024, and November 4, 2024 as well as inconclusive media fill results and other significant quality events. Your firm lacked timely and adequate media fill investigations. For instance, your root causes were unsupported and lacked effective corrective actions.
Following the inspection, you committed to recalling (b)(4) batches of drug products made from (b)(4) which reflects the timeframe between the failing media fills. In addition, you commit to improving your quality unit (QU) escalation procedures to ensure proper awareness and to engaging an outside consultant to provide oversight of your QU for six months.
Your response is inadequate. You did not provide a retrospective review of all media fills to ensure additional deviations, atypical events, and unexpected results during commercial manufacturing were adequately represented in your media fill programs.
Poor Practices in the Aseptic Processing Areas
We observed poor practices and behaviors in ISO 5 areas during commercial operations and media fills. These poor practices, included but are not limited to:
* Operators inserting their upper torso into the (b)(4) restricted access barrier system ((b)(4)RABS) during interventions, breaching the ISO 5 barrier.
* An operator performing a (b)(4) RABS intervention directly with the (b)(4)RABS (b)(4) instead of using forceps.
* Shorter operators opening the (b)(4)RABS (b)(4) and bypassing the (b)(4) during difficult-to-reach interventions, while taller operators used the (b)(4)RABS (b)(4).
In your response, you commit to retraining the operators on appropriate aseptic behaviors. Also, you commit to revising procedures and engaging outside consultants to review practices.
Your response is inadequate. You do not address how you plan to ensure operators follow appropriate procedures in the future, including supervisory and quality assurance oversight. Additionally, these poor aseptic practices were not investigated to determine the impact to sterile drug products manufactured under these conditions and distributed to the U.S. market. Your response also fails to reevaluate your aseptic processing design. Specifically, you do not identify and evaluate hazards posed by various manual activities (e.g., planned interventions, unplanned interventions, (b)(4)) or address the risks that insufficient design poses.
Airflow Visualization Studies (AVS) and Process Design
Our inspection identified aseptic processing design deficiencies which pose significant hazards to drug product sterility, as well as multiple inadequacies in your airflow visualization studies (i.e., smoke studies). For example, unidirectional airflow could not be evaluated in certain AVS. There were interventions performed in which the camera is placed behind the operator and the impact of the intervention on the airflow cannot be visualized.
Our inspection also noted other AVS deficiencies. For example, the smoke source was not always positioned at the HEPA filter face to confirm unidirectional airflow and uniform velocity. We previously discussed inadequate smoke studies in our August 3, 2023, Warning Letter issued to your firm.
In addition, the worst-case locations for environmental monitoring of the ISO 5 filling room and (b)(4)RABS have not been defined through adequate risk assessment.
In your response, you commit to suspending filling operations until remediation activities, including improvements to AVS, are completed. You also acknowledge appropriate smoke studies are required to demonstrate unidirectional airflow patterns and proper aseptic techniques and behaviors are critical elements of sterility assurance. You commit to improve your smoke study protocol with the assistance of external consultants and to re-execute smoke studies in ISO 5, 7, and 8 areas prior to resuming operations.
Your response is inadequate. You did not address how drug products made with inadequate aseptic processing design and distributed to the U.S. market will be evaluated to ensure their sterility assurance. Your response also fails to consider line design changes that would minimize the need for frequent operator interaction with the aseptic processing line.
See FDA's guidance document Sterile Drug Products Produced by Aseptic Processing--Current Good Manufacturing Practice to help you meet the CGMP requirements when manufacturing sterile drugs using aseptic processing at https://www.fda.gov/media/71026/download.
In response to this letter:
* Provide your action plan to address any product quality or patient safety risks for your drug products in U.S. distribution, including potential customer notifications and recalls.
* Review prior "passing" aseptic process simulations (media fills) for previously missed deviations, unusual activities, and unexpected results. Explain actions taken to evaluate and address the acceptability of (b)(4) drugs produced using your aseptic filling process that were distributed to the U.S. market.
* Perform a critical evaluation of airflow unidirectionality in your aseptic process, with the assistance of a qualified consultant. Ensure smoke studies are conducted under dynamic conditions, with thorough and complete evaluations of aseptic processing line airflow unidirectionality, including the impact of dynamic interactions and aseptic interventions. These thorough smoke studies should be performed after you remediate your aseptic operation and be conducted using proper practices (e.g., (b)(4)) to appropriately visualize airflow.
* Provide your systematic plan to assure adherence to appropriate aseptic practices, cleanroom behavior, and written procedures, including but not limited to an independent assessment of the following with accompanying corrective and preventive action (CAPA):
- Suitability of actual practices based on extensive retrospective review and prospective observation of aseptic processing operations.
- Deficiencies in production management oversight, and identification of specific improvements to ensure effective and routine supervisory oversight for all batches
- Frequency and depth of QU oversight (e.g., audit, ad hoc, daily interactions) of aseptic processing and its support operations.
- Adequacy of written procedures.
- Evaluation of the impact poor aseptic technique and cleanroom behavior may have had on the sterility of your drugs.
* Provide a comprehensive, independent risk assessment of all contamination hazards with respect to your aseptic processes, equipment, and facilities, including but not limited to:
- All human interactions within the ISO 5 area (e.g., risk reduction or elimination of manual interventions wherever possible).
- Equipment suitability (e.g., reliability, capability, ergonomics, placement) and sufficient cleanroom space.
- Air quality in the ISO 5 area and surrounding room including, but not limited to air volume and flow.
- Facility layout.
- Personnel flow and material flow (movement throughout all rooms used to conduct and support sterile operations, and all material transfers).
- Specific CAPA recommendations that will comprehensively address the design and control hazards identified in the risk assessment.
- A detailed remediation plan with timelines to address the findings of the contamination hazards risk assessment. Describe specific tangible improvements to be made to aseptic processing operation design and control at your facility and explain how this CAPA plan will robustly remediate your deficient sterile manufacturing operations. Include comprehensive changes to the design of both your aseptic processing lines and cleanrooms. Also, describe your plans for qualification and validation of your extensively remediated operations.
2. Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).
Your post-fill visual inspection of aseptically filled over-the-counter (OTC) (b)(4) drug products was insufficient to identify particulate matter and defects which may be present in each unit. Your drug product containers are (b)(4), and only very slightly (b)(4), and particulates can be seen through them readily, which does not meet the criteria for "difficult to inspect." For example, your firm only conducted subvisible particulate testing on a sample of units based on your assertion that the bottles were (b)(4) and not suitable for visual inspection. Further, your Acceptable Quality Limit (AQL) testing was designed to examine for filling, labeling, and packaging defects only, and did not include defect categories for particulates or foreign matter.
Your firm's inadequate visual inspection program provides insufficient assurance to prevent release of (b)(4) drug products with particulate matter or foreign material defects.
In your response, you acknowledge that 100% visual inspection is not performed and that you lack the proper procedures and/or equipment. You commit to modifying your visual inspection program to include the reliable detection of particulate contamination and other visible defects prior to resuming production operations.
Your response is inadequate. Although you commit to evaluating the visual inspection program and replacing the (b)(4), you did not consider a combination of (b)(4) inspection methods to ensure detection of the wide array of potential visible product defects. Also, you did not consider the impact of particulates or foreign matter in (b)(4) drug products that were distributed to the U.S. market.
We encourage the use of suitable (b)(4) visual inspection for particulates to augment the 100% (b)(4) visual inspection program. (b)(4) methods should be rigorously studied, and qualified, to assess their capability and robustness under various conditions, machine settings, container-closure sizes, defect types, product characteristic, and other variables. In addition, any use of (b)(4) particulate inspection as an adjunct method does not supplant the need for 100% (b)(4) visual inspection, for various other attributes (e.g., cracks, deformities, closure issues, volume, insufficient crimping, leaks, (b)(4), discoloration, turbidity, other appearance defects).
In addition, your firm failed to provide adequate data to demonstrate manufacturing systems were adequately maintained, operated, and monitored. For example, you lacked a formalized process and procedure for responding to your (b)(4) alarms. Alarms occurred at multiple timepoints from 2024 to 2026 without documented evidence of a systematic or appropriate response. OTC (b)(4) drug products manufactured at your firm use (b)(4) as the main component for each formulation.
Further, your firm has not completed commitments made during the Regulatory Meeting held January 10, 2025.
In your response, you commit to creating new procedures for the (b)(4) maintenance and operation, including responding to alarms and performing a comprehensive review of alarm histories to determine if notable alarms require further investigation.
Your response is inadequate. You did not provide documentation or details on the review of alarms for potential impact to drug products made with (b)(4) from your (b)(4).
We acknowledge that you are using an independent third-party consultant to evaluate your visual inspection program. You should consider performing a comprehensive assessment and remediation plan for your visual inspection program to ensure compliance with CGMP. The remediation plan should incorporate U.S. Pharmacopeia (USP) <790> Visible Particulates in Injections and USP <771> (b)(4) Products-Quality Tests, including container-specific testing protocols (e.g., (b)(4)) for each container type. Your strategy should include:
* Implementing 100% visible inspection using enhanced lighting with background contrast methods, as appropriate, for difficult-to-inspect products (DIP) (e.g., (b)(4) containers) that allow visual inspection.
* For drug products that preclude visual inspection (e.g., products packaged in (b)(4) containers), using destructive testing (e.g., subvisible particulate matter) with appropriate, statistically significant sample sizes to test for critical defects.
* Where traditional visual inspection methods cannot be used, establishing periodic in-process visible particulate matter testing for both bulk solution and fill/finish operations to ensure process control, and implementing enhanced manufacturing controls, including strengthened (b)(4) and environmental controls.
* Developing a product-specific, risk-based visual inspection approach incorporating product knowledge, process experience, deviation investigation analysis, and recall/complaint data to ensure ongoing compliance with USP <790>, USP <771>, and CGMP requirements.
Additionally, in response to this letter, provide:
* An evaluation of customer and clients' complaints received for potential particulates that were overlooked due to use of inadequate defect criteria during visual inspection.
* A comprehensive remediation plan for the design, control, and maintenance of the (b)(4), including:
o A (b)(4) system validation report. Also include the summary of any improvements made to system design and to the program for ongoing control and maintenance.
* Your total microbial count limits to monitor whether this system is producing (b)(4) suitable for the intended uses for each of your drug products.
* A detailed risk assessment addressing the potential effects of the observed (b)(4) failures on the quality of all drug product lots currently in U.S. distribution or within expiry. Specify actions that you will take in response to the risk assessment, such as customer notifications and product recalls.
* A procedure for your (b)(4) monitoring that specifies routine microbial testing of (b)(4) to ensure its acceptability for use in each batch of drug products produced by your firm.
* The current action/alert limits for total counts and objectionable organisms used for your (b)(4). Ensure that the total count limits for your (b)(4) are appropriately stringent in view of the intended use of each of the drug products produced by your firm. Total microbial count limits for (b)(4) systems are generally tighter than your current/proposed action and alert limits for the (b)(4) liquid dosage forms produced by your firm.
* A procedure governing your program for ongoing control, maintenance, and monitoring that ensures the remediated system consistently produces (b)(4) that meets the USP (b)(4) monograph specifications and appropriate microbial limits.
3. Your firm failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products (21 CFR 211.166(a)).
Your firm has not established stability indicating methods for the OTC (b)(4) drug products you distribute to the U.S. market. For example, the validation protocol for the assay of Naphazoline HCl (NPZ) in the (b)(4) formulation detailed a stress study; however, the report stated that the stress study would be performed later and reported separately. Assay for NPZ is a test conducted for stability studies of the (b)(4) formulation. Without forced degradations studies to establish specificity, the accuracy of the test assay results cannot be assured throughout the shelf-life of the product during stability.
In your response, you acknowledge that initial forced degradation studies for the current OTC (b)(4) formulations could not be located, and you commit to repeating these studies and creating an action plan based on the results. In addition, you commit to conducting a three-year retrospective review for the active pharmaceutical ingredient (API) testing during stability for each product code and to conducting a review of prior annual product reviews to evaluate any stability trends observed for the API and preservative systems for each product code.
Proper document control and data management is foundational to CGMP to ensure the availability and integrity of data. Data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA) to ensure complete and accurate records.
Your response is inadequate. Your review of retrospective data using methods that have not been validated as stability indicating provides insufficient confidence in your marketed drug products. Upon development of your stability indicating methods, you should add additional batches to your stability program, including retains of older batches (e.g., (b)(4)). You did not assess the impact of inadequate stability testing and the potential for degradation products in OTC (b)(4) drug products within expiry distributed to the U.S. market.
In response to this letter, provide:
* A comprehensive independent assessment of your laboratory practices, procedures, methods, equipment, documentation, and analyst competencies. Based on this review, provide a detailed plan to remediate and evaluate the effectiveness of your laboratory system.
* A comprehensive independent assessment and CAPA plan to ensure the adequacy of your stability program. Your remediated program should include, but not be limited to:
- Stability indicating methods.
- Stability studies for each drug product in its marketed container-closure system before distribution is permitted.
- An ongoing program in which representative batches of each product are added each year to the program to determine whether the shelf-life claim remains valid
- Detailed definition of the specific attributes to be tested at each station (timepoint), as part of a program that encompasses each quality attribute that may change over the product shelf-life.
- All procedures that describe these and other elements of your remediated stability program.
* A commitment to notify FDA within 3 days of any stability failures.
4. Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR (211.160(b)).
Your firm did not adequately perform system suitability testing for laboratory equipment before testing your (b)(4) and other critical samples. For example, your firm routinely performed total organic carbon (TOC) and conductivity measurements without prior system suitability of the analyzer.
In your response, you acknowledge inadequate procedural requirements and insufficient analyst and supervisor training for performing day-of-use system suitability. You commit to revising procedures and to holistically investigate other test methods.
Your response is inadequate. You did not provide details of your review of historical system suitability results that concluded there were no adverse trends for drug products on the market within expiry. Additionally, you did not address the lack of system suitability performance for the other examples cited on the Form FDA 483 and did not expand the review to other laboratory systems beyond the TOC and conductivity systems or retrospectively review results generated with the other systems for accuracy.
In response to this letter, provide:
* A comprehensive independent assessment of your laboratory practices, procedures, methods, equipment, documentation, and analyst competencies. Based on this review, provide a detailed plan to remediate and evaluate the effectiveness of your laboratory system.
* Your retrospective review of system suitability results from laboratory equipment used to generate data in support of drug product manufacturing and release for distribution, including risk assessments and remediation plans.
5. Your firm failed to establish adequate written responsibilities and procedures applicable to the quality control unit and to follow written procedures applicable to the quality control unit (21 CFR 211.22(d)).
Complaint Handling
Your QU did not adequately ensure procedures were established and followed. For example, your procedure for customer complaints and inquiries is inadequate. Your approach to determining severity and adverse events resulted in delayed and incomplete investigations. Additionally, investigations were based on the client and not the severity of the complaint. Also, adequate complaint investigations were not completed in a timely manner.
In your response, you commit to revising your procedure and reviewing past complaints to ensure serious events are properly investigated.
Your response is inadequate. You did not provide the status of open complaint investigations or whether additional complaints have been received since the close of the inspection.
Stability Program
Your QU failed to ensure stability testing was conducted according to your program procedures. Your firm missed stability time points, missed stability tests, or performed incorrect tests on batches placed into your stability program.
In your response, you acknowledge the lack of proper QU oversight of the stability program. You commit to performing an impact assessment with the assistance of external consultants and revising your stability program procedure.
Your response is inadequate. You did not provide details on how the impact of incomplete stability testing will be assessed for product batches that have been distributed to the US. market.
In response to this letter, provide:
* A comprehensive, independent review of your overall complaint system, including a retrospective review of all complaints for the last three years from the initial date of the inspection, with an assessment that includes but is not limited to:
- Nature of complaint, and potential associated risk.
- Date of first notification and subsequent contacts with complainant.
- Timing and sufficiency of followups with complainant to obtain photographs and the complaint sample, as well as to obtain any additional contextual information. Determine relevant complaint samples were available and extent of efforts to obtain the complaint sample. If insufficient attempts were made, identify the root cause(s) for not adequately pursuing their return.
- Review of long-term history for similar or same defects.
- Identification of potential causes of the defect that led to the complaint, including evaluation whether the scientific justification and evidence relating to the identified root cause(s) were adequately documented. In the event a complaint was attributed to factors outside of the firm's control (e.g., user error), assess the strength of this determination and whether it was based on conclusive or inconclusive information.
- CAPA steps taken, including but not limited to manufacturing/quality improvements (e.g., manufacturing operation, raw materials, supplier, quality control), as well as recalls or heightened quality surveillance (additional testing/examinations, adding batch to stability program).
- For all complaint investigations found by the retrospective review to be deficient due to insufficient root cause or CAPA, perform a thorough analysis of production (e.g., batch manufacturing records, adequacy of the manufacturing steps, suitability of equipment/facilities, variability of raw materials, process capability, deviation history, complaint history, out-of-specification history, batch failure history).
- Based upon this independent review, provide a comprehensive assessment of the complaint system that identifies all deficiencies and needed improvements.
- The status of your review of open complaint investigations and whether additional complaints have been received since the procedure has been revised.
* A comprehensive, independent assessment and CAPA plan to ensure the adequacy of your stability program. Your remediated program should include, but not be limited to:
- Stability indicating methods.
- Stability studies for each drug product in its marketed container-closure system before distribution is permitted.
- An ongoing program in which representative batches of each product are added each year to the program to determine whether the shelf-life claim remains valid.
- Detailed definition of the specific attributes to be tested at each station (timepoint), as part of a program that encompasses each quality attribute that may change over the product shelf-life.
- All procedures that describe these and other elements of your remediated stability program.
Your firm's quality systems are inadequate. See FDA's guidance document, Quality Systems Approach to Pharmaceutical CGMP Regulations, for help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211 at https://www.fda.gov/media/71023/download.
Quality Unit Authority
Your inspectional history indicates that your QU is not able to fully exercise its authority and/or responsibilities. Your firm must provide the QU with the appropriate authority and sufficient resources to carry out its responsibilities and consistently ensure drug quality.
Drug Production Suspended
We acknowledge your commitment to suspend production of all OTC (b)(4) drug products at this facility.
If you plan to resume any manufacturing operations regulated under the FD&C Act, notify this office before resuming your drug manufacturing operations. You are responsible for resolving all deficiencies and systemic flaws to ensure your firm is capable of ongoing CGMP compliance. In your notification to the Agency, provide a summary of your remediations to demonstrate that you have appropriately completed all CAPA.
Drug Recall
On February 18, 2026, you initiated a voluntary recall of all commercial drug products manufactured between March 27, 2024, and November 7, 2024 due to failing media fills and a lack of sterility assurance. The company announcement was posted to the FDA website at:
* https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=218993
* https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=219008
* https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=219030
* https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=219049
* https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=219055
* https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=219061
* https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=219063
* https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=219064
Repeat Violations at Facility
In a previous warning letter (issued August 3, 2023), FDA cited similar severe CGMP violations. The recurrence of these violations demonstrates that your firm's corrective actions were neither effective nor durable. Notably, your failure to correct these issues led to unacceptable drug product being distributed to the U.S. market.
CGMP Consultant
Based upon the nature of the violations we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 211.34 to evaluate your operations and to assist your firm in meeting CGMP requirements if your firm intends to resume manufacturing drugs for the U.S. market. The qualified consultant should also perform a comprehensive six-system audit/1 of your entire operation for CGMP compliance and evaluate the completion and efficacy of your CAPA before you pursue resolution of your firm's compliance status with FDA.
Your use of a consultant does not relieve your firm's obligation to comply with CGMP. Your firm's executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.
Request for a Meeting with FDA
After you submit your response to this warning letter, we recommend you reach out to this office to arrange for a teleconference to discuss your CAPA in detail. Please direct your request to Christina Reyes at christina.reyes@fda.hhs.gov and cc: CDER-OC-OMQ-Communications@fda.hhs.gov.
Conclusion
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.
Correct any violations promptly. Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure and injunction. Unresolved violations may also prevent other Federal agencies from awarding contracts.
Failure to address violations may also cause FDA to withhold issuance of export certificates. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any violations.
This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days/2. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.
Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 2026940 and ATTN: Carrie A. Hughes.
Sincerely,
/S/ Francis Godwin, Director, Office of Manufacturing Quality, Office of Compliance, Center for Drug Evaluation and Research
* * *
Footnotes:
1/ i.e. Quality System, Facilities & Equipment System, Materials System, Production System, Packaging & Labeling System, and Laboratory Control System per FDA's guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations.
2/ Under program enhancements for the Generic Drug User Fee Amendments (GDUFA) reauthorization for fiscal years (FYs) 2023-2027, also known as the GDUFA III Commitment Letter, your facility may be eligible for a Post-Warning Letter Meeting to obtain preliminary feedback from FDA on the adequacy and completeness of your corrective action plans.
* * *
Original text here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/kc-pharmaceuticals-inc-729870-08122026
* * *
Recipient: Ms. Ratnawati Li, Chief Executive Officer, K.C. Pharmaceuticals, Inc., 3420 Pomona Blvd., Pomona, CA 91768, United States
Issuing Office: Center for Drug Evaluation and Research (CDER), United States
Warning Letter 320-26-112
Dear Ms. Li:
The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, K.C. Pharmaceuticals, Inc., ... Show Full Article WASHINGTON, Aug. 19 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to K.C. Pharmaceuticals Inc. from its Center for Drug Evaluation and Research: * * * Recipient: Ms. Ratnawati Li, Chief Executive Officer, K.C. Pharmaceuticals, Inc., 3420 Pomona Blvd., Pomona, CA 91768, United States Issuing Office: Center for Drug Evaluation and Research (CDER), United States Warning Letter 320-26-112 Dear Ms. Li: The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, K.C. Pharmaceuticals, Inc.,FEI 2026940, at 3420 Pomona Blvd., Pomona, CA, from January 20 to February 13, 2026.
This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).
Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).
We reviewed your March 10, 2026, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.
During our inspection, our investigators observed specific violations including, but not limited to, the following.
1. Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)).
Media Fills
Your firm continued to manufacture and release sterile drug products manufactured by aseptic processing following media fill failures on June 21, 2024, September 4, 2024, and November 4, 2024 as well as inconclusive media fill results and other significant quality events. Your firm lacked timely and adequate media fill investigations. For instance, your root causes were unsupported and lacked effective corrective actions.
Following the inspection, you committed to recalling (b)(4) batches of drug products made from (b)(4) which reflects the timeframe between the failing media fills. In addition, you commit to improving your quality unit (QU) escalation procedures to ensure proper awareness and to engaging an outside consultant to provide oversight of your QU for six months.
Your response is inadequate. You did not provide a retrospective review of all media fills to ensure additional deviations, atypical events, and unexpected results during commercial manufacturing were adequately represented in your media fill programs.
Poor Practices in the Aseptic Processing Areas
We observed poor practices and behaviors in ISO 5 areas during commercial operations and media fills. These poor practices, included but are not limited to:
* Operators inserting their upper torso into the (b)(4) restricted access barrier system ((b)(4)RABS) during interventions, breaching the ISO 5 barrier.
* An operator performing a (b)(4) RABS intervention directly with the (b)(4)RABS (b)(4) instead of using forceps.
* Shorter operators opening the (b)(4)RABS (b)(4) and bypassing the (b)(4) during difficult-to-reach interventions, while taller operators used the (b)(4)RABS (b)(4).
In your response, you commit to retraining the operators on appropriate aseptic behaviors. Also, you commit to revising procedures and engaging outside consultants to review practices.
Your response is inadequate. You do not address how you plan to ensure operators follow appropriate procedures in the future, including supervisory and quality assurance oversight. Additionally, these poor aseptic practices were not investigated to determine the impact to sterile drug products manufactured under these conditions and distributed to the U.S. market. Your response also fails to reevaluate your aseptic processing design. Specifically, you do not identify and evaluate hazards posed by various manual activities (e.g., planned interventions, unplanned interventions, (b)(4)) or address the risks that insufficient design poses.
Airflow Visualization Studies (AVS) and Process Design
Our inspection identified aseptic processing design deficiencies which pose significant hazards to drug product sterility, as well as multiple inadequacies in your airflow visualization studies (i.e., smoke studies). For example, unidirectional airflow could not be evaluated in certain AVS. There were interventions performed in which the camera is placed behind the operator and the impact of the intervention on the airflow cannot be visualized.
Our inspection also noted other AVS deficiencies. For example, the smoke source was not always positioned at the HEPA filter face to confirm unidirectional airflow and uniform velocity. We previously discussed inadequate smoke studies in our August 3, 2023, Warning Letter issued to your firm.
In addition, the worst-case locations for environmental monitoring of the ISO 5 filling room and (b)(4)RABS have not been defined through adequate risk assessment.
In your response, you commit to suspending filling operations until remediation activities, including improvements to AVS, are completed. You also acknowledge appropriate smoke studies are required to demonstrate unidirectional airflow patterns and proper aseptic techniques and behaviors are critical elements of sterility assurance. You commit to improve your smoke study protocol with the assistance of external consultants and to re-execute smoke studies in ISO 5, 7, and 8 areas prior to resuming operations.
Your response is inadequate. You did not address how drug products made with inadequate aseptic processing design and distributed to the U.S. market will be evaluated to ensure their sterility assurance. Your response also fails to consider line design changes that would minimize the need for frequent operator interaction with the aseptic processing line.
See FDA's guidance document Sterile Drug Products Produced by Aseptic Processing--Current Good Manufacturing Practice to help you meet the CGMP requirements when manufacturing sterile drugs using aseptic processing at https://www.fda.gov/media/71026/download.
In response to this letter:
* Provide your action plan to address any product quality or patient safety risks for your drug products in U.S. distribution, including potential customer notifications and recalls.
* Review prior "passing" aseptic process simulations (media fills) for previously missed deviations, unusual activities, and unexpected results. Explain actions taken to evaluate and address the acceptability of (b)(4) drugs produced using your aseptic filling process that were distributed to the U.S. market.
* Perform a critical evaluation of airflow unidirectionality in your aseptic process, with the assistance of a qualified consultant. Ensure smoke studies are conducted under dynamic conditions, with thorough and complete evaluations of aseptic processing line airflow unidirectionality, including the impact of dynamic interactions and aseptic interventions. These thorough smoke studies should be performed after you remediate your aseptic operation and be conducted using proper practices (e.g., (b)(4)) to appropriately visualize airflow.
* Provide your systematic plan to assure adherence to appropriate aseptic practices, cleanroom behavior, and written procedures, including but not limited to an independent assessment of the following with accompanying corrective and preventive action (CAPA):
- Suitability of actual practices based on extensive retrospective review and prospective observation of aseptic processing operations.
- Deficiencies in production management oversight, and identification of specific improvements to ensure effective and routine supervisory oversight for all batches
- Frequency and depth of QU oversight (e.g., audit, ad hoc, daily interactions) of aseptic processing and its support operations.
- Adequacy of written procedures.
- Evaluation of the impact poor aseptic technique and cleanroom behavior may have had on the sterility of your drugs.
* Provide a comprehensive, independent risk assessment of all contamination hazards with respect to your aseptic processes, equipment, and facilities, including but not limited to:
- All human interactions within the ISO 5 area (e.g., risk reduction or elimination of manual interventions wherever possible).
- Equipment suitability (e.g., reliability, capability, ergonomics, placement) and sufficient cleanroom space.
- Air quality in the ISO 5 area and surrounding room including, but not limited to air volume and flow.
- Facility layout.
- Personnel flow and material flow (movement throughout all rooms used to conduct and support sterile operations, and all material transfers).
- Specific CAPA recommendations that will comprehensively address the design and control hazards identified in the risk assessment.
- A detailed remediation plan with timelines to address the findings of the contamination hazards risk assessment. Describe specific tangible improvements to be made to aseptic processing operation design and control at your facility and explain how this CAPA plan will robustly remediate your deficient sterile manufacturing operations. Include comprehensive changes to the design of both your aseptic processing lines and cleanrooms. Also, describe your plans for qualification and validation of your extensively remediated operations.
2. Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).
Your post-fill visual inspection of aseptically filled over-the-counter (OTC) (b)(4) drug products was insufficient to identify particulate matter and defects which may be present in each unit. Your drug product containers are (b)(4), and only very slightly (b)(4), and particulates can be seen through them readily, which does not meet the criteria for "difficult to inspect." For example, your firm only conducted subvisible particulate testing on a sample of units based on your assertion that the bottles were (b)(4) and not suitable for visual inspection. Further, your Acceptable Quality Limit (AQL) testing was designed to examine for filling, labeling, and packaging defects only, and did not include defect categories for particulates or foreign matter.
Your firm's inadequate visual inspection program provides insufficient assurance to prevent release of (b)(4) drug products with particulate matter or foreign material defects.
In your response, you acknowledge that 100% visual inspection is not performed and that you lack the proper procedures and/or equipment. You commit to modifying your visual inspection program to include the reliable detection of particulate contamination and other visible defects prior to resuming production operations.
Your response is inadequate. Although you commit to evaluating the visual inspection program and replacing the (b)(4), you did not consider a combination of (b)(4) inspection methods to ensure detection of the wide array of potential visible product defects. Also, you did not consider the impact of particulates or foreign matter in (b)(4) drug products that were distributed to the U.S. market.
We encourage the use of suitable (b)(4) visual inspection for particulates to augment the 100% (b)(4) visual inspection program. (b)(4) methods should be rigorously studied, and qualified, to assess their capability and robustness under various conditions, machine settings, container-closure sizes, defect types, product characteristic, and other variables. In addition, any use of (b)(4) particulate inspection as an adjunct method does not supplant the need for 100% (b)(4) visual inspection, for various other attributes (e.g., cracks, deformities, closure issues, volume, insufficient crimping, leaks, (b)(4), discoloration, turbidity, other appearance defects).
In addition, your firm failed to provide adequate data to demonstrate manufacturing systems were adequately maintained, operated, and monitored. For example, you lacked a formalized process and procedure for responding to your (b)(4) alarms. Alarms occurred at multiple timepoints from 2024 to 2026 without documented evidence of a systematic or appropriate response. OTC (b)(4) drug products manufactured at your firm use (b)(4) as the main component for each formulation.
Further, your firm has not completed commitments made during the Regulatory Meeting held January 10, 2025.
In your response, you commit to creating new procedures for the (b)(4) maintenance and operation, including responding to alarms and performing a comprehensive review of alarm histories to determine if notable alarms require further investigation.
Your response is inadequate. You did not provide documentation or details on the review of alarms for potential impact to drug products made with (b)(4) from your (b)(4).
We acknowledge that you are using an independent third-party consultant to evaluate your visual inspection program. You should consider performing a comprehensive assessment and remediation plan for your visual inspection program to ensure compliance with CGMP. The remediation plan should incorporate U.S. Pharmacopeia (USP) <790> Visible Particulates in Injections and USP <771> (b)(4) Products-Quality Tests, including container-specific testing protocols (e.g., (b)(4)) for each container type. Your strategy should include:
* Implementing 100% visible inspection using enhanced lighting with background contrast methods, as appropriate, for difficult-to-inspect products (DIP) (e.g., (b)(4) containers) that allow visual inspection.
* For drug products that preclude visual inspection (e.g., products packaged in (b)(4) containers), using destructive testing (e.g., subvisible particulate matter) with appropriate, statistically significant sample sizes to test for critical defects.
* Where traditional visual inspection methods cannot be used, establishing periodic in-process visible particulate matter testing for both bulk solution and fill/finish operations to ensure process control, and implementing enhanced manufacturing controls, including strengthened (b)(4) and environmental controls.
* Developing a product-specific, risk-based visual inspection approach incorporating product knowledge, process experience, deviation investigation analysis, and recall/complaint data to ensure ongoing compliance with USP <790>, USP <771>, and CGMP requirements.
Additionally, in response to this letter, provide:
* An evaluation of customer and clients' complaints received for potential particulates that were overlooked due to use of inadequate defect criteria during visual inspection.
* A comprehensive remediation plan for the design, control, and maintenance of the (b)(4), including:
o A (b)(4) system validation report. Also include the summary of any improvements made to system design and to the program for ongoing control and maintenance.
* Your total microbial count limits to monitor whether this system is producing (b)(4) suitable for the intended uses for each of your drug products.
* A detailed risk assessment addressing the potential effects of the observed (b)(4) failures on the quality of all drug product lots currently in U.S. distribution or within expiry. Specify actions that you will take in response to the risk assessment, such as customer notifications and product recalls.
* A procedure for your (b)(4) monitoring that specifies routine microbial testing of (b)(4) to ensure its acceptability for use in each batch of drug products produced by your firm.
* The current action/alert limits for total counts and objectionable organisms used for your (b)(4). Ensure that the total count limits for your (b)(4) are appropriately stringent in view of the intended use of each of the drug products produced by your firm. Total microbial count limits for (b)(4) systems are generally tighter than your current/proposed action and alert limits for the (b)(4) liquid dosage forms produced by your firm.
* A procedure governing your program for ongoing control, maintenance, and monitoring that ensures the remediated system consistently produces (b)(4) that meets the USP (b)(4) monograph specifications and appropriate microbial limits.
3. Your firm failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products (21 CFR 211.166(a)).
Your firm has not established stability indicating methods for the OTC (b)(4) drug products you distribute to the U.S. market. For example, the validation protocol for the assay of Naphazoline HCl (NPZ) in the (b)(4) formulation detailed a stress study; however, the report stated that the stress study would be performed later and reported separately. Assay for NPZ is a test conducted for stability studies of the (b)(4) formulation. Without forced degradations studies to establish specificity, the accuracy of the test assay results cannot be assured throughout the shelf-life of the product during stability.
In your response, you acknowledge that initial forced degradation studies for the current OTC (b)(4) formulations could not be located, and you commit to repeating these studies and creating an action plan based on the results. In addition, you commit to conducting a three-year retrospective review for the active pharmaceutical ingredient (API) testing during stability for each product code and to conducting a review of prior annual product reviews to evaluate any stability trends observed for the API and preservative systems for each product code.
Proper document control and data management is foundational to CGMP to ensure the availability and integrity of data. Data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA) to ensure complete and accurate records.
Your response is inadequate. Your review of retrospective data using methods that have not been validated as stability indicating provides insufficient confidence in your marketed drug products. Upon development of your stability indicating methods, you should add additional batches to your stability program, including retains of older batches (e.g., (b)(4)). You did not assess the impact of inadequate stability testing and the potential for degradation products in OTC (b)(4) drug products within expiry distributed to the U.S. market.
In response to this letter, provide:
* A comprehensive independent assessment of your laboratory practices, procedures, methods, equipment, documentation, and analyst competencies. Based on this review, provide a detailed plan to remediate and evaluate the effectiveness of your laboratory system.
* A comprehensive independent assessment and CAPA plan to ensure the adequacy of your stability program. Your remediated program should include, but not be limited to:
- Stability indicating methods.
- Stability studies for each drug product in its marketed container-closure system before distribution is permitted.
- An ongoing program in which representative batches of each product are added each year to the program to determine whether the shelf-life claim remains valid
- Detailed definition of the specific attributes to be tested at each station (timepoint), as part of a program that encompasses each quality attribute that may change over the product shelf-life.
- All procedures that describe these and other elements of your remediated stability program.
* A commitment to notify FDA within 3 days of any stability failures.
4. Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR (211.160(b)).
Your firm did not adequately perform system suitability testing for laboratory equipment before testing your (b)(4) and other critical samples. For example, your firm routinely performed total organic carbon (TOC) and conductivity measurements without prior system suitability of the analyzer.
In your response, you acknowledge inadequate procedural requirements and insufficient analyst and supervisor training for performing day-of-use system suitability. You commit to revising procedures and to holistically investigate other test methods.
Your response is inadequate. You did not provide details of your review of historical system suitability results that concluded there were no adverse trends for drug products on the market within expiry. Additionally, you did not address the lack of system suitability performance for the other examples cited on the Form FDA 483 and did not expand the review to other laboratory systems beyond the TOC and conductivity systems or retrospectively review results generated with the other systems for accuracy.
In response to this letter, provide:
* A comprehensive independent assessment of your laboratory practices, procedures, methods, equipment, documentation, and analyst competencies. Based on this review, provide a detailed plan to remediate and evaluate the effectiveness of your laboratory system.
* Your retrospective review of system suitability results from laboratory equipment used to generate data in support of drug product manufacturing and release for distribution, including risk assessments and remediation plans.
5. Your firm failed to establish adequate written responsibilities and procedures applicable to the quality control unit and to follow written procedures applicable to the quality control unit (21 CFR 211.22(d)).
Complaint Handling
Your QU did not adequately ensure procedures were established and followed. For example, your procedure for customer complaints and inquiries is inadequate. Your approach to determining severity and adverse events resulted in delayed and incomplete investigations. Additionally, investigations were based on the client and not the severity of the complaint. Also, adequate complaint investigations were not completed in a timely manner.
In your response, you commit to revising your procedure and reviewing past complaints to ensure serious events are properly investigated.
Your response is inadequate. You did not provide the status of open complaint investigations or whether additional complaints have been received since the close of the inspection.
Stability Program
Your QU failed to ensure stability testing was conducted according to your program procedures. Your firm missed stability time points, missed stability tests, or performed incorrect tests on batches placed into your stability program.
In your response, you acknowledge the lack of proper QU oversight of the stability program. You commit to performing an impact assessment with the assistance of external consultants and revising your stability program procedure.
Your response is inadequate. You did not provide details on how the impact of incomplete stability testing will be assessed for product batches that have been distributed to the US. market.
In response to this letter, provide:
* A comprehensive, independent review of your overall complaint system, including a retrospective review of all complaints for the last three years from the initial date of the inspection, with an assessment that includes but is not limited to:
- Nature of complaint, and potential associated risk.
- Date of first notification and subsequent contacts with complainant.
- Timing and sufficiency of followups with complainant to obtain photographs and the complaint sample, as well as to obtain any additional contextual information. Determine relevant complaint samples were available and extent of efforts to obtain the complaint sample. If insufficient attempts were made, identify the root cause(s) for not adequately pursuing their return.
- Review of long-term history for similar or same defects.
- Identification of potential causes of the defect that led to the complaint, including evaluation whether the scientific justification and evidence relating to the identified root cause(s) were adequately documented. In the event a complaint was attributed to factors outside of the firm's control (e.g., user error), assess the strength of this determination and whether it was based on conclusive or inconclusive information.
- CAPA steps taken, including but not limited to manufacturing/quality improvements (e.g., manufacturing operation, raw materials, supplier, quality control), as well as recalls or heightened quality surveillance (additional testing/examinations, adding batch to stability program).
- For all complaint investigations found by the retrospective review to be deficient due to insufficient root cause or CAPA, perform a thorough analysis of production (e.g., batch manufacturing records, adequacy of the manufacturing steps, suitability of equipment/facilities, variability of raw materials, process capability, deviation history, complaint history, out-of-specification history, batch failure history).
- Based upon this independent review, provide a comprehensive assessment of the complaint system that identifies all deficiencies and needed improvements.
- The status of your review of open complaint investigations and whether additional complaints have been received since the procedure has been revised.
* A comprehensive, independent assessment and CAPA plan to ensure the adequacy of your stability program. Your remediated program should include, but not be limited to:
- Stability indicating methods.
- Stability studies for each drug product in its marketed container-closure system before distribution is permitted.
- An ongoing program in which representative batches of each product are added each year to the program to determine whether the shelf-life claim remains valid.
- Detailed definition of the specific attributes to be tested at each station (timepoint), as part of a program that encompasses each quality attribute that may change over the product shelf-life.
- All procedures that describe these and other elements of your remediated stability program.
Your firm's quality systems are inadequate. See FDA's guidance document, Quality Systems Approach to Pharmaceutical CGMP Regulations, for help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211 at https://www.fda.gov/media/71023/download.
Quality Unit Authority
Your inspectional history indicates that your QU is not able to fully exercise its authority and/or responsibilities. Your firm must provide the QU with the appropriate authority and sufficient resources to carry out its responsibilities and consistently ensure drug quality.
Drug Production Suspended
We acknowledge your commitment to suspend production of all OTC (b)(4) drug products at this facility.
If you plan to resume any manufacturing operations regulated under the FD&C Act, notify this office before resuming your drug manufacturing operations. You are responsible for resolving all deficiencies and systemic flaws to ensure your firm is capable of ongoing CGMP compliance. In your notification to the Agency, provide a summary of your remediations to demonstrate that you have appropriately completed all CAPA.
Drug Recall
On February 18, 2026, you initiated a voluntary recall of all commercial drug products manufactured between March 27, 2024, and November 7, 2024 due to failing media fills and a lack of sterility assurance. The company announcement was posted to the FDA website at:
* https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=218993
* https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=219008
* https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=219030
* https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=219049
* https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=219055
* https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=219061
* https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=219063
* https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=219064
Repeat Violations at Facility
In a previous warning letter (issued August 3, 2023), FDA cited similar severe CGMP violations. The recurrence of these violations demonstrates that your firm's corrective actions were neither effective nor durable. Notably, your failure to correct these issues led to unacceptable drug product being distributed to the U.S. market.
CGMP Consultant
Based upon the nature of the violations we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 211.34 to evaluate your operations and to assist your firm in meeting CGMP requirements if your firm intends to resume manufacturing drugs for the U.S. market. The qualified consultant should also perform a comprehensive six-system audit/1 of your entire operation for CGMP compliance and evaluate the completion and efficacy of your CAPA before you pursue resolution of your firm's compliance status with FDA.
Your use of a consultant does not relieve your firm's obligation to comply with CGMP. Your firm's executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.
Request for a Meeting with FDA
After you submit your response to this warning letter, we recommend you reach out to this office to arrange for a teleconference to discuss your CAPA in detail. Please direct your request to Christina Reyes at christina.reyes@fda.hhs.gov and cc: CDER-OC-OMQ-Communications@fda.hhs.gov.
Conclusion
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.
Correct any violations promptly. Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure and injunction. Unresolved violations may also prevent other Federal agencies from awarding contracts.
Failure to address violations may also cause FDA to withhold issuance of export certificates. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any violations.
This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days/2. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.
Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 2026940 and ATTN: Carrie A. Hughes.
Sincerely,
/S/ Francis Godwin, Director, Office of Manufacturing Quality, Office of Compliance, Center for Drug Evaluation and Research
* * *
Footnotes:
1/ i.e. Quality System, Facilities & Equipment System, Materials System, Production System, Packaging & Labeling System, and Laboratory Control System per FDA's guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations.
2/ Under program enhancements for the Generic Drug User Fee Amendments (GDUFA) reauthorization for fiscal years (FYs) 2023-2027, also known as the GDUFA III Commitment Letter, your facility may be eligible for a Post-Warning Letter Meeting to obtain preliminary feedback from FDA on the adequacy and completeness of your corrective action plans.
* * *
Original text here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/kc-pharmaceuticals-inc-729870-08122026
DOE Office of Environmental Management: Major Deactivation Progress Moves Oak Ridge Reactor Closer to Teardown
WASHINGTON, Aug. 19 -- The Department of Energy Office of Environmental Management issued the following news release:
* * *
Major Deactivation Progress Moves Oak Ridge Reactor Closer to Teardown
OAK RIDGE, Tenn. -- The Oak Ridge Office of Environmental Management has made significant headway deactivating the Oak Ridge Research Reactor since crews successfully removed its reactor vessel two years ago.
With the extracted vessel loaded into a 32,000-pound protective shipping cask for offsite disposal, crews shifted focus to address hazards in the basement of the large facility in the central campus ... Show Full Article WASHINGTON, Aug. 19 -- The Department of Energy Office of Environmental Management issued the following news release: * * * Major Deactivation Progress Moves Oak Ridge Reactor Closer to Teardown OAK RIDGE, Tenn. -- The Oak Ridge Office of Environmental Management has made significant headway deactivating the Oak Ridge Research Reactor since crews successfully removed its reactor vessel two years ago. With the extracted vessel loaded into a 32,000-pound protective shipping cask for offsite disposal, crews shifted focus to address hazards in the basement of the large facility in the central campusof Oak Ridge National Laboratory (ORNL), bringing the structure a step closer to demolition.
"Removing the reactor was a tremendous accomplishment, but it also opened the door to the next phase of cleanup," said UCOR Project Manager Steven Reed. "Our crews continue making steady progress every day, safely removing contaminated systems and preparing the building for the work that will ultimately lead to demolition. It's complex work, but every milestone brings us one step closer to completing this mission."
Deactivation progress at the reactor takes place alongside multiple cleanup projects reshaping ORNL's central campus. Together, these projects eliminate hazards, clear aging nuclear infrastructure and open space for modernization to support future scientific discoveries.
Operating from 1958 until its shutdown in 1987, the reactor supported groundbreaking neutron research, isotope production, materials testing and reactor development, helping establish Oak Ridge as a global leader in nuclear science.
Decades of research also left behind highly contaminated systems and infrastructure requiring deactivation before crews can safely take down the building.
Workers have rid the facility of more than 160 waste containers, 16,000 linear feet of contaminated piping, six gloveboxes and approximately 300,000 pounds of lead shielding while continuing extensive characterization activities. They expect to finish clearing remaining radiologically contaminated equipment from the basement this year. Next, crews will move to the upper floors to address additional piping and equipment removal.
Following deactivation, crews will place a concrete-like mixture throughout the lower level to create a stable foundation to support future demolition equipment.
Demolition is expected to begin in 2029.
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Original text here: https://www.energy.gov/em/articles/major-deactivation-progress-moves-oak-ridge-reactor-closer-teardown
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Major Deactivation Progress Moves Oak Ridge Reactor Closer to Teardown
OAK RIDGE, Tenn. -- The Oak Ridge Office of Environmental Management has made significant headway deactivating the Oak Ridge Research Reactor since crews successfully removed its reactor vessel two years ago.
With the extracted vessel loaded into a 32,000-pound protective shipping cask for offsite disposal, crews shifted focus to address hazards in the basement of the large facility in the central campus ... Show Full Article WASHINGTON, Aug. 19 -- The Department of Energy Office of Environmental Management issued the following news release: * * * Major Deactivation Progress Moves Oak Ridge Reactor Closer to Teardown OAK RIDGE, Tenn. -- The Oak Ridge Office of Environmental Management has made significant headway deactivating the Oak Ridge Research Reactor since crews successfully removed its reactor vessel two years ago. With the extracted vessel loaded into a 32,000-pound protective shipping cask for offsite disposal, crews shifted focus to address hazards in the basement of the large facility in the central campusof Oak Ridge National Laboratory (ORNL), bringing the structure a step closer to demolition.
"Removing the reactor was a tremendous accomplishment, but it also opened the door to the next phase of cleanup," said UCOR Project Manager Steven Reed. "Our crews continue making steady progress every day, safely removing contaminated systems and preparing the building for the work that will ultimately lead to demolition. It's complex work, but every milestone brings us one step closer to completing this mission."
Deactivation progress at the reactor takes place alongside multiple cleanup projects reshaping ORNL's central campus. Together, these projects eliminate hazards, clear aging nuclear infrastructure and open space for modernization to support future scientific discoveries.
Operating from 1958 until its shutdown in 1987, the reactor supported groundbreaking neutron research, isotope production, materials testing and reactor development, helping establish Oak Ridge as a global leader in nuclear science.
Decades of research also left behind highly contaminated systems and infrastructure requiring deactivation before crews can safely take down the building.
Workers have rid the facility of more than 160 waste containers, 16,000 linear feet of contaminated piping, six gloveboxes and approximately 300,000 pounds of lead shielding while continuing extensive characterization activities. They expect to finish clearing remaining radiologically contaminated equipment from the basement this year. Next, crews will move to the upper floors to address additional piping and equipment removal.
Following deactivation, crews will place a concrete-like mixture throughout the lower level to create a stable foundation to support future demolition equipment.
Demolition is expected to begin in 2029.
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Original text here: https://www.energy.gov/em/articles/major-deactivation-progress-moves-oak-ridge-reactor-closer-teardown
Bureau of Transportation Statistics: Intercity Bus Atlas Departs the Station
WASHINGTON, Aug. 19 -- The U.S. Department of Transportation Bureau of Transportation Statistics issued the following news:
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Intercity Bus Atlas Departs the Station
The Bureau of Transportation Statistics (BTS) announces the relaunch of the Intercity Bus Atlas, an interactive, digital mapping application of scheduled, intercity passenger bus services in the United States.
The Atlas now features the newest stop and route information from a group of nearly 60 scheduled intercity bus providers, all of whom volunteered their schedule and network data to BTS for this project. The updated map ... Show Full Article WASHINGTON, Aug. 19 -- The U.S. Department of Transportation Bureau of Transportation Statistics issued the following news: * * * Intercity Bus Atlas Departs the Station The Bureau of Transportation Statistics (BTS) announces the relaunch of the Intercity Bus Atlas, an interactive, digital mapping application of scheduled, intercity passenger bus services in the United States. The Atlas now features the newest stop and route information from a group of nearly 60 scheduled intercity bus providers, all of whom volunteered their schedule and network data to BTS for this project. The updated mapfeatures approximately 3,500 stops from 1,800 routes, representing scheduled services across the entire United States.
This update underscores BTS as the federal home of the only regularly-updated, comprehensive, public map of the scheduled intercity bus network of the United States. This revitalized tool provides researchers, policymakers, and planners with national-level data on the availability and connectivity of a mode of long-distance passenger transportation missing from previous statistical and cartographic products.
Users are welcome to download the geospatial files representing the stops and routes of the national network from the National Transportation Atlas Database (https://www.bts.gov/ntad).
BTS will update the Intercity Bus Atlas on a quarterly basis, using the newest schedule and network data from participating carriers. Future versions of the ICBA will include additional carriers as well as more information on route and stop frequency.
For more information, or to ask questions about the ICBA, contact icba@dot.gov.
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Original text here: https://www.bts.gov/newsroom/intercity-bus-atlas-departs-station
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Intercity Bus Atlas Departs the Station
The Bureau of Transportation Statistics (BTS) announces the relaunch of the Intercity Bus Atlas, an interactive, digital mapping application of scheduled, intercity passenger bus services in the United States.
The Atlas now features the newest stop and route information from a group of nearly 60 scheduled intercity bus providers, all of whom volunteered their schedule and network data to BTS for this project. The updated map ... Show Full Article WASHINGTON, Aug. 19 -- The U.S. Department of Transportation Bureau of Transportation Statistics issued the following news: * * * Intercity Bus Atlas Departs the Station The Bureau of Transportation Statistics (BTS) announces the relaunch of the Intercity Bus Atlas, an interactive, digital mapping application of scheduled, intercity passenger bus services in the United States. The Atlas now features the newest stop and route information from a group of nearly 60 scheduled intercity bus providers, all of whom volunteered their schedule and network data to BTS for this project. The updated mapfeatures approximately 3,500 stops from 1,800 routes, representing scheduled services across the entire United States.
This update underscores BTS as the federal home of the only regularly-updated, comprehensive, public map of the scheduled intercity bus network of the United States. This revitalized tool provides researchers, policymakers, and planners with national-level data on the availability and connectivity of a mode of long-distance passenger transportation missing from previous statistical and cartographic products.
Users are welcome to download the geospatial files representing the stops and routes of the national network from the National Transportation Atlas Database (https://www.bts.gov/ntad).
BTS will update the Intercity Bus Atlas on a quarterly basis, using the newest schedule and network data from participating carriers. Future versions of the ICBA will include additional carriers as well as more information on route and stop frequency.
For more information, or to ask questions about the ICBA, contact icba@dot.gov.
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Original text here: https://www.bts.gov/newsroom/intercity-bus-atlas-departs-station