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Treasury IG: Audit of the Financial Stability Oversight Council's Designation of Nonbank Financial Companies
WASHINGTON, Aug. 5 -- The Treasury Inspector General issued the following audit report on July 1, 2026, entitled "Audit of the Financial Stability Oversight Council's Designation of Nonbank Financial Companies."
Here are excerpts:
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Background
The Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act) established the Financial Stability Oversight Council (FSOC or Council) to identify risks to the U.S. financial stability, promote market discipline, and respond to emerging threats.2 FSOC is chaired by the Secretary of the Department of the Treasury (Treasury) and includes ... Show Full Article WASHINGTON, Aug. 5 -- The Treasury Inspector General issued the following audit report on July 1, 2026, entitled "Audit of the Financial Stability Oversight Council's Designation of Nonbank Financial Companies." Here are excerpts: * * * Background The Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act) established the Financial Stability Oversight Council (FSOC or Council) to identify risks to the U.S. financial stability, promote market discipline, and respond to emerging threats.2 FSOC is chaired by the Secretary of the Department of the Treasury (Treasury) and includesfederal financial regulators, an independent insurance expert appointed by the President, and state regulators. Within Treasury, the FSOC Secretariat, led by a Deputy Assistant Secretary, coordinates the Council's work among its members and member agencies.
The Dodd-Frank Act also created the Council of Inspectors General on Financial Oversight (CIGFO), whose members include the Inspectors General with oversight authority for the majority of FSOC's member agencies. CIGFO is authorized to convene Working Groups to evaluate FSOC's effectiveness and internal operations.4 In March 2024, CIGFO established a Working Group, led by the Treasury Office of Inspector General, to assess FSOC's process for designating nonbank financial companies.5 Our audit focused on FSOC's 2023 Interpretive Guidance as it existed during the audit period. The proposed revisions to the guidance FSOC issued in March 2026 were not included in the scope of this audit.
Objectives, Scope, and Methodology
Our audit objectives were to assess (1) the sufficiency of the "Financial Stability Oversight Council Guidance for Nonbank Financial Company Determinations" (2023 Interpretive Guidance) to effectively respond to financial stability threats under Section 113 of the Dodd-Frank Act; (2) the extent that the FSOC members were engaged in the development of the 2023 Interpretive Guidance considering such factors as lessons learned and any identified barriers from earlier guidance; and (3) the impact on the nonbank designation process as a result of the 2023 Interpretive Guidance compared to the "Authority to Require Supervision and Regulation of Certain Nonbank Financial Companies" guidance (2012 and 2019 Guidance) and process.
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The report is posted at: https://oig.treasury.gov/system/files/2026-07/FSOC%27s-Designation-of-Nonbank-Financial-Companies-508-Compliant-and-Locked.pdf
Here are excerpts:
* * *
Background
The Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act) established the Financial Stability Oversight Council (FSOC or Council) to identify risks to the U.S. financial stability, promote market discipline, and respond to emerging threats.2 FSOC is chaired by the Secretary of the Department of the Treasury (Treasury) and includes ... Show Full Article WASHINGTON, Aug. 5 -- The Treasury Inspector General issued the following audit report on July 1, 2026, entitled "Audit of the Financial Stability Oversight Council's Designation of Nonbank Financial Companies." Here are excerpts: * * * Background The Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act) established the Financial Stability Oversight Council (FSOC or Council) to identify risks to the U.S. financial stability, promote market discipline, and respond to emerging threats.2 FSOC is chaired by the Secretary of the Department of the Treasury (Treasury) and includesfederal financial regulators, an independent insurance expert appointed by the President, and state regulators. Within Treasury, the FSOC Secretariat, led by a Deputy Assistant Secretary, coordinates the Council's work among its members and member agencies.
The Dodd-Frank Act also created the Council of Inspectors General on Financial Oversight (CIGFO), whose members include the Inspectors General with oversight authority for the majority of FSOC's member agencies. CIGFO is authorized to convene Working Groups to evaluate FSOC's effectiveness and internal operations.4 In March 2024, CIGFO established a Working Group, led by the Treasury Office of Inspector General, to assess FSOC's process for designating nonbank financial companies.5 Our audit focused on FSOC's 2023 Interpretive Guidance as it existed during the audit period. The proposed revisions to the guidance FSOC issued in March 2026 were not included in the scope of this audit.
Objectives, Scope, and Methodology
Our audit objectives were to assess (1) the sufficiency of the "Financial Stability Oversight Council Guidance for Nonbank Financial Company Determinations" (2023 Interpretive Guidance) to effectively respond to financial stability threats under Section 113 of the Dodd-Frank Act; (2) the extent that the FSOC members were engaged in the development of the 2023 Interpretive Guidance considering such factors as lessons learned and any identified barriers from earlier guidance; and (3) the impact on the nonbank designation process as a result of the 2023 Interpretive Guidance compared to the "Authority to Require Supervision and Regulation of Certain Nonbank Financial Companies" guidance (2012 and 2019 Guidance) and process.
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The report is posted at: https://oig.treasury.gov/system/files/2026-07/FSOC%27s-Designation-of-Nonbank-Financial-Companies-508-Compliant-and-Locked.pdf
Treasury IG for Tax Administration: Actions Were Taken to Address Security Deficiencies at IRS Facilities
WASHINGTON, Aug. 5 (TNSLrpt) -- The Treasury Inspector General for Tax Administration issued the following report (No. 2026-IE-R011) on July 29, 2026, entitled "Actions Were Taken to Address Security Deficiencies at IRS Facilities."
Here are excerpts:
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Why TIGTA Did This Inspection
From June 2022 through November 2024, we issued 5 reports on unannounced physical security inspections at 16 IRS facilities. Our inspections determined whether IRS facilities had safety and security measures in place to detect and deter unauthorized entry, and whether the measures complied with established ... Show Full Article WASHINGTON, Aug. 5 (TNSLrpt) -- The Treasury Inspector General for Tax Administration issued the following report (No. 2026-IE-R011) on July 29, 2026, entitled "Actions Were Taken to Address Security Deficiencies at IRS Facilities." Here are excerpts: * * * Why TIGTA Did This Inspection From June 2022 through November 2024, we issued 5 reports on unannounced physical security inspections at 16 IRS facilities. Our inspections determined whether IRS facilities had safety and security measures in place to detect and deter unauthorized entry, and whether the measures complied with establishedstandards. We made 42 recommendations to improve and/or repair existing countermeasures.
Additionally, in August 2023, the IRS completed its comprehensive security review of its facilities. That review included 500 IRS facilities and resulted in 593 recommendations to improve and/or repair existing security countermeasures and addressed noncompliance issues.
We initiated this follow-up inspection to assess actions that the IRS has taken to address facility security deficiencies. This included assessing IRS actions taken to address prior TIGTA recommendations related to select facility security deficiencies.
Impact on Tax Administration As of January 2026, approximately 74,000 IRS employees work in roughly 500 IRS facilities. Threats and assaults directed at IRS employees and facilities impede the effective and safe administration of the federal tax system.
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The report is posted at: https://www.tigta.gov/sites/default/files/reports/2026-07/2026ier011fr.pdf
Here are excerpts:
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Why TIGTA Did This Inspection
From June 2022 through November 2024, we issued 5 reports on unannounced physical security inspections at 16 IRS facilities. Our inspections determined whether IRS facilities had safety and security measures in place to detect and deter unauthorized entry, and whether the measures complied with established ... Show Full Article WASHINGTON, Aug. 5 (TNSLrpt) -- The Treasury Inspector General for Tax Administration issued the following report (No. 2026-IE-R011) on July 29, 2026, entitled "Actions Were Taken to Address Security Deficiencies at IRS Facilities." Here are excerpts: * * * Why TIGTA Did This Inspection From June 2022 through November 2024, we issued 5 reports on unannounced physical security inspections at 16 IRS facilities. Our inspections determined whether IRS facilities had safety and security measures in place to detect and deter unauthorized entry, and whether the measures complied with establishedstandards. We made 42 recommendations to improve and/or repair existing countermeasures.
Additionally, in August 2023, the IRS completed its comprehensive security review of its facilities. That review included 500 IRS facilities and resulted in 593 recommendations to improve and/or repair existing security countermeasures and addressed noncompliance issues.
We initiated this follow-up inspection to assess actions that the IRS has taken to address facility security deficiencies. This included assessing IRS actions taken to address prior TIGTA recommendations related to select facility security deficiencies.
Impact on Tax Administration As of January 2026, approximately 74,000 IRS employees work in roughly 500 IRS facilities. Threats and assaults directed at IRS employees and facilities impede the effective and safe administration of the federal tax system.
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The report is posted at: https://www.tigta.gov/sites/default/files/reports/2026-07/2026ier011fr.pdf
SEC Settles Case Against Former New Jersey Corrections Officer Charged in Alleged Crypto Offering and Investment Fraud Schemes
WASHINGTON, Aug. 5 -- The Securities and Exchange Commission issued the following litigation release:
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Securities and Exchange Commission v. John A. DeSalvo., No. 23-cv-8092-RMB-EAP (D.N.J. filed Aug. 23, 2023)
On August 4, 2026, the Securities and Exchange Commission filed a consent and proposed final judgment in the U.S. District Court for the District of New Jersey as to defendant John A. DeSalvo, a former New Jersey Corrections Officer, in connection with a previously filed action alleging that DeSalvo engaged in crypto offering and investment fraud schemes.
The Commission's complaint, ... Show Full Article WASHINGTON, Aug. 5 -- The Securities and Exchange Commission issued the following litigation release: * * * Securities and Exchange Commission v. John A. DeSalvo., No. 23-cv-8092-RMB-EAP (D.N.J. filed Aug. 23, 2023) On August 4, 2026, the Securities and Exchange Commission filed a consent and proposed final judgment in the U.S. District Court for the District of New Jersey as to defendant John A. DeSalvo, a former New Jersey Corrections Officer, in connection with a previously filed action alleging that DeSalvo engaged in crypto offering and investment fraud schemes. The Commission's complaint,filed on August 23, 2023, alleges that DeSalvo fraudulently raised at least $623,888 from approximately 222 investors in connection with the so-called Blazar Token. As the complaint alleges, DeSalvo claimed that the Blazar Token would replace traditional state pension systems and falsely told investors that Blazar Token was registered with the SEC; that he had arranged for Blazar Token to be purchased by automatic payroll deduction; and that investors were guaranteed to receive extraordinary returns. Additionally, the SEC's complaint alleges that, in an earlier fraud scheme, beginning in late January 2021, DeSalvo fraudulently raised approximately $95,000 from 17 investors to participate in an investment program that DeSalvo claimed would invest in stocks, options, and crypto assets.
DeSalvo consented to the entry of a final judgment, subject to court approval, that would permanently enjoin him from violating Sections 5(a), 5(c), and 17(a) of the Securities Act of 1933 and Section 10(b) of the Exchange Act of 1934 and Rule 10b-5 thereunder; impose a conduct-based injunction permanently enjoining him from participating in the issuance, offer, or sale of any security; and order him liable for disgorgement in the amount of $681,105, which shall be deemed satisfied by the order of restitution entered against him in a parallel criminal matter, United States v. DeSalvo, No. 24-cr-200-BRM (D.N.J.).
The SEC's litigation was handled by Christopher R. Kelly and supervised by Gregory R. Bockin of the SEC's Philadelphia Regional Office. The SEC's investigation was conducted by Brian Higgins and Brian Thomas of the Philadelphia Regional Office and David W. Snyder of the Division of Enforcement's Market Abuse Unit. The investigation was supervised by Assunta Vivolo, Scott A. Thompson, and Laura D'Allaird.
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Original text here: https://www.sec.gov/enforcement-litigation/litigation-releases/lr-26599
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Securities and Exchange Commission v. John A. DeSalvo., No. 23-cv-8092-RMB-EAP (D.N.J. filed Aug. 23, 2023)
On August 4, 2026, the Securities and Exchange Commission filed a consent and proposed final judgment in the U.S. District Court for the District of New Jersey as to defendant John A. DeSalvo, a former New Jersey Corrections Officer, in connection with a previously filed action alleging that DeSalvo engaged in crypto offering and investment fraud schemes.
The Commission's complaint, ... Show Full Article WASHINGTON, Aug. 5 -- The Securities and Exchange Commission issued the following litigation release: * * * Securities and Exchange Commission v. John A. DeSalvo., No. 23-cv-8092-RMB-EAP (D.N.J. filed Aug. 23, 2023) On August 4, 2026, the Securities and Exchange Commission filed a consent and proposed final judgment in the U.S. District Court for the District of New Jersey as to defendant John A. DeSalvo, a former New Jersey Corrections Officer, in connection with a previously filed action alleging that DeSalvo engaged in crypto offering and investment fraud schemes. The Commission's complaint,filed on August 23, 2023, alleges that DeSalvo fraudulently raised at least $623,888 from approximately 222 investors in connection with the so-called Blazar Token. As the complaint alleges, DeSalvo claimed that the Blazar Token would replace traditional state pension systems and falsely told investors that Blazar Token was registered with the SEC; that he had arranged for Blazar Token to be purchased by automatic payroll deduction; and that investors were guaranteed to receive extraordinary returns. Additionally, the SEC's complaint alleges that, in an earlier fraud scheme, beginning in late January 2021, DeSalvo fraudulently raised approximately $95,000 from 17 investors to participate in an investment program that DeSalvo claimed would invest in stocks, options, and crypto assets.
DeSalvo consented to the entry of a final judgment, subject to court approval, that would permanently enjoin him from violating Sections 5(a), 5(c), and 17(a) of the Securities Act of 1933 and Section 10(b) of the Exchange Act of 1934 and Rule 10b-5 thereunder; impose a conduct-based injunction permanently enjoining him from participating in the issuance, offer, or sale of any security; and order him liable for disgorgement in the amount of $681,105, which shall be deemed satisfied by the order of restitution entered against him in a parallel criminal matter, United States v. DeSalvo, No. 24-cr-200-BRM (D.N.J.).
The SEC's litigation was handled by Christopher R. Kelly and supervised by Gregory R. Bockin of the SEC's Philadelphia Regional Office. The SEC's investigation was conducted by Brian Higgins and Brian Thomas of the Philadelphia Regional Office and David W. Snyder of the Division of Enforcement's Market Abuse Unit. The investigation was supervised by Assunta Vivolo, Scott A. Thompson, and Laura D'Allaird.
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Original text here: https://www.sec.gov/enforcement-litigation/litigation-releases/lr-26599
FDA Human Foods Program Issues Warning Letter to Friend's Stable & Orchard Inc.
WASHINGTON, Aug. 5 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Friend's Stable and Orchard Inc. from its Human Foods Program:
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Recipient: Robert G. Kittredge, Owner, Friend's Stable and Orchard, Inc., 3562 Grand Ave., Ojai, CA 93023-9307, United States
Issuing Office: Human Foods Program, United States
WARNING LETTER
CMS # 728680
Dear Mr. Robert G. Kittredge:
The California Department of Food and Agriculture (CDFA) under the U.S. Food and Drug Administration's authority, inspected your farm located at 3562 Grand ... Show Full Article WASHINGTON, Aug. 5 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Friend's Stable and Orchard Inc. from its Human Foods Program: * * * Recipient: Robert G. Kittredge, Owner, Friend's Stable and Orchard, Inc., 3562 Grand Ave., Ojai, CA 93023-9307, United States Issuing Office: Human Foods Program, United States WARNING LETTER CMS # 728680 Dear Mr. Robert G. Kittredge: The California Department of Food and Agriculture (CDFA) under the U.S. Food and Drug Administration's authority, inspected your farm located at 3562 GrandAve., Ojai, CA 93023-9307 on March 23, 2026, through March 25, 2026. Our inspection revealed a serious violation of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption regulation (Produce Safety regulation), Title 21, Code of Federal Regulations, Part 112 (21 CFR Part 112).
Based on the inspectional findings, we have determined that your Navel oranges, Valencia oranges, and Pixie mandarins are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. Sec. 342(a)(4)], in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or whereby they may have been rendered injurious to health. In addition, failure to comply with the Produce Safety regulation is a prohibited act under section 301(vv) of the Act [21 U.S.C. Sec. 331(vv)]. You can find the Act and FDA's regulations through links on FDA's home page at http://www.fda.gov.
The inspection resulted in FDA's issuance of a Form FDA 4056 (FDA 4056), Produce Farm Inspectional Observations. To date, we have not received a response to the issued FDA 4056; however, we did receive your written response, dated April 22, 2026, to a call we held with you on April 1, 2026.
We address your response below.
During the inspection, the FDA investigator observed the following significant violation of the Produce Safety Regulation, 21 CFR Part 112:
1. You did not apply untreated biological soil amendments of animal origin in a manner that does not contact covered produce during application, as required by 21 CFR 112.56(a)(1).
Specifically, the investigator observed raw (b)(4) manure in the canopy of citrus trees and in contact with growing oranges. During the inspection, you stated that the untreated manure is applied (b)(4) to the (b)(4) rows meant to (b)(4) ((b)(4) rows). You stated that raw (b)(4) manure is applied using a (b)(4) that distributes it (b)(4) of the row. The (b)(4) distributes manure using (b)(4). The investigator observed untreated (b)(4) manure in the canopies of at least (b)(4) Valencia orange trees in (b)(4) rows in the (b)(4) of Block (b)(4). Additionally, (b)(4) of those same trees in (b)(4) rows had untreated (b)(4) manure observed sitting directly on growing oranges.
We acknowledge that during the inspection, you proposed the following potential corrective actions regarding the use of the (b)(4): applying untreated (b)(4) manure only to (b)(4) rows at a sufficient distance to prevent contact with growing fruit or creating a (b)(4). We also acknowledge your response, dated April 22, 2026, to the April 1, 2026, call. In that response, you stated that you will be conducting a (b)(4) inspection regarding growing Navel oranges, Valencia oranges, and Pixie mandarins to determine if they should be (b)(4) as a result of coming into contact with untreated biological soil amendments of animal origin. We will evaluate the adequacy of your corrective actions at our next inspection.
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. You should take prompt action to correct any violations. Failure to adequately address any violation may lead to legal action including, without limitation, seizure and injunction.
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps that you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Please send your reply to the Food and Drug Administration, Attention: Rochelle R. Blair, Compliance Officer, electronically to producefarminspection@fda.hhs.gov. If you have questions regarding any issues in this letter, please contact Rochelle R. Blair at (949) 608-4496 or at producefarminspection@fda.hhs.gov.
Sincerely,
/S/ Maria S. Knirk, JD, MBA, Director, Office of Enforcement, Office of Compliance and Enforcement, Human Foods Program, U.S. Food and Drug Administration
CC: (b)(5)
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Original text here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/friends-stable-and-orchard-inc-728680-07142026
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Recipient: Robert G. Kittredge, Owner, Friend's Stable and Orchard, Inc., 3562 Grand Ave., Ojai, CA 93023-9307, United States
Issuing Office: Human Foods Program, United States
WARNING LETTER
CMS # 728680
Dear Mr. Robert G. Kittredge:
The California Department of Food and Agriculture (CDFA) under the U.S. Food and Drug Administration's authority, inspected your farm located at 3562 Grand ... Show Full Article WASHINGTON, Aug. 5 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Friend's Stable and Orchard Inc. from its Human Foods Program: * * * Recipient: Robert G. Kittredge, Owner, Friend's Stable and Orchard, Inc., 3562 Grand Ave., Ojai, CA 93023-9307, United States Issuing Office: Human Foods Program, United States WARNING LETTER CMS # 728680 Dear Mr. Robert G. Kittredge: The California Department of Food and Agriculture (CDFA) under the U.S. Food and Drug Administration's authority, inspected your farm located at 3562 GrandAve., Ojai, CA 93023-9307 on March 23, 2026, through March 25, 2026. Our inspection revealed a serious violation of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption regulation (Produce Safety regulation), Title 21, Code of Federal Regulations, Part 112 (21 CFR Part 112).
Based on the inspectional findings, we have determined that your Navel oranges, Valencia oranges, and Pixie mandarins are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. Sec. 342(a)(4)], in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or whereby they may have been rendered injurious to health. In addition, failure to comply with the Produce Safety regulation is a prohibited act under section 301(vv) of the Act [21 U.S.C. Sec. 331(vv)]. You can find the Act and FDA's regulations through links on FDA's home page at http://www.fda.gov.
The inspection resulted in FDA's issuance of a Form FDA 4056 (FDA 4056), Produce Farm Inspectional Observations. To date, we have not received a response to the issued FDA 4056; however, we did receive your written response, dated April 22, 2026, to a call we held with you on April 1, 2026.
We address your response below.
During the inspection, the FDA investigator observed the following significant violation of the Produce Safety Regulation, 21 CFR Part 112:
1. You did not apply untreated biological soil amendments of animal origin in a manner that does not contact covered produce during application, as required by 21 CFR 112.56(a)(1).
Specifically, the investigator observed raw (b)(4) manure in the canopy of citrus trees and in contact with growing oranges. During the inspection, you stated that the untreated manure is applied (b)(4) to the (b)(4) rows meant to (b)(4) ((b)(4) rows). You stated that raw (b)(4) manure is applied using a (b)(4) that distributes it (b)(4) of the row. The (b)(4) distributes manure using (b)(4). The investigator observed untreated (b)(4) manure in the canopies of at least (b)(4) Valencia orange trees in (b)(4) rows in the (b)(4) of Block (b)(4). Additionally, (b)(4) of those same trees in (b)(4) rows had untreated (b)(4) manure observed sitting directly on growing oranges.
We acknowledge that during the inspection, you proposed the following potential corrective actions regarding the use of the (b)(4): applying untreated (b)(4) manure only to (b)(4) rows at a sufficient distance to prevent contact with growing fruit or creating a (b)(4). We also acknowledge your response, dated April 22, 2026, to the April 1, 2026, call. In that response, you stated that you will be conducting a (b)(4) inspection regarding growing Navel oranges, Valencia oranges, and Pixie mandarins to determine if they should be (b)(4) as a result of coming into contact with untreated biological soil amendments of animal origin. We will evaluate the adequacy of your corrective actions at our next inspection.
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. You should take prompt action to correct any violations. Failure to adequately address any violation may lead to legal action including, without limitation, seizure and injunction.
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps that you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Please send your reply to the Food and Drug Administration, Attention: Rochelle R. Blair, Compliance Officer, electronically to producefarminspection@fda.hhs.gov. If you have questions regarding any issues in this letter, please contact Rochelle R. Blair at (949) 608-4496 or at producefarminspection@fda.hhs.gov.
Sincerely,
/S/ Maria S. Knirk, JD, MBA, Director, Office of Enforcement, Office of Compliance and Enforcement, Human Foods Program, U.S. Food and Drug Administration
CC: (b)(5)
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Original text here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/friends-stable-and-orchard-inc-728680-07142026
FDA Center for Drug Evaluation & Research Issues Warning Letter to Dabur India
WASHINGTON, Aug. 5 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Dabur India Limited from its Center for Drug Evaluation and Research:
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Recipient: Mr. Mohit Malhotra, Chief Executive Officer, Dabur India Limited, Dabur Corporate Office, Kaushambi, Sahibabad, Ghaziabad 201010, India
Issuing Office: Center for Drug Evaluation and Research (CDER), United States
Warning Letter 320-26-105
Dear Mr. Malhotra:
The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Dabur India Limited, ... Show Full Article WASHINGTON, Aug. 5 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Dabur India Limited from its Center for Drug Evaluation and Research: * * * Recipient: Mr. Mohit Malhotra, Chief Executive Officer, Dabur India Limited, Dabur Corporate Office, Kaushambi, Sahibabad, Ghaziabad 201010, India Issuing Office: Center for Drug Evaluation and Research (CDER), United States Warning Letter 320-26-105 Dear Mr. Malhotra: The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Dabur India Limited,FEI 3001413302, at Survey No. 225/4/1, Village: Saily, Silvassa, Dadra and Nagar Haveli and Daman and Diu, from January 12 to 16, 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 February 4, 2026 response to our Form FDA 483 in detail.
During our inspection, our investigator observed specific violations including, but not limited to, the following.
1. Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products and the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated (21 CFR 211.22(a)).
Your firm manufactures over-the-counter drug products including (b)(4) and (b)(4). Your quality unit (QU) failed to exercise its authority and responsibilities over your drug manufacturing operations, including ensuring the integrity of your production records.
During the inspection, our investigator requested the equipment usage logbook for Unit (b)(4), Line (b)(4), which your management stated was dedicated exclusively to (b)(4) manufacturing. Your firm delayed providing this record for several days. When your firm finally produced the logbook, it appeared to have been newly created. Subsequently, our investigator discovered the original logbook in the document room. A comparison of the two logbooks revealed that the version provided to our investigator was falsified. The fraudulent logbook listed entries only for (b)(4). It deliberately omitted multiple U.S. marketed OTC drug products that were documented in the original logbook, including (b)(4).
Furthermore, our investigator identified multiple discrepancies between the source data in your analytical data books and the final values reported in your batch manufacturing records or certificates of analysis. For multiple batches of (b)(4) and (b)(4), the reported values for quality attributes such as residue on ignition, melting range, pH, and viscosity did not match the original data. While these inaccuracies did not involve out-of-specification results, your QU signed off on these records without ensuring the consistency and accuracy of the data.
In your response, you acknowledge these deficiencies, attributing the falsified logbook to "inadequate documentation controls, insufficient oversight, and lack of robust governance." You attributed other data inaccuracies to your transcription practices and inadequate resources within your QU for proper review. You state that you trained personnel on data integrity and committed to revising procedures and reviewing only the (b)(4) of data for similar transcription errors. You also commit to sending "(b)(4) samples of impacted drug product including (b)(4)" to a contract testing laboratory.
Your response is inadequate because it fails to address the severity of the observed data integrity failures. Your proposed corrective actions address the data integrity breaches as isolated procedural gaps rather than as evidence of a systemic breakdown in QU oversight and a deficient quality culture. Your response does not address the fundamental failure of your QU to ensure the integrity and completeness of all data related to your drug manufacturing operations, nor does it include an adequate assessment of the potential impact on the quality of drug products already distributed to the U.S. market. Furthermore, your response lacks a sufficient comprehensive evaluation of your QU's capabilities to fulfill all required quality-related functions.
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.
In response to this letter, provide:
* A comprehensive assessment of documentation systems used throughout your manufacturing and laboratory operations to determine where documentation practices are insufficient. Include a detailed corrective action and preventive action (CAPA) plan that comprehensively remediates your firm's documentation practices to ensure you retain attributable, legible, complete, original, accurate, contemporaneous records throughout your operation.
* A comprehensive assessment and remediation plan to ensure your QU is given the authority and resources to effectively function. The assessment should also include, but not be limited to:
- A determination of whether procedures used by your firm are robust and appropriate
- Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices
- A complete and final review of each batch and its related information before the QU disposition decision
- Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products.
2. Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards (21 CFR 211.194(a)).
Your laboratory records did not include complete data to support the analyses performed. For example, your analytical notebooks documented approximately (b)(4) microbiology plates for finished drug products and approximately (b)(4) media plates for testing (b)(4) samples as incubated, but the plates were physically absent from incubators with no documented explanation about their whereabouts or disposal. In addition, during the inspection you could not produce the test procedures, analytical workbooks, or test data sheets to support the reported certificate of analysis results for approximately (b)(4) batches of U.S. marketed drug products. You also failed to make the required entries in your equipment logbooks to reflect the use of multiple instruments for the specific batch release tests performed.
In your response, you indicate that a microbiologist inadvertently discarded the missing microbiological plates due to lack of training. You state that you retrained the microbiologist, re-analyzed the missing finished drug product plates, and introduced a new controlled logbook to improve sample traceability.
Regarding the batches released without supporting analytical records, you commit to sending samples for several of the batches to a contract laboratory for retrospective testing and to implementing formal test data sheets for future data recording. Further, you state that you have retrained the personnel responsible for failing to document instrument usage and that you will discontinue the use of separate equipment usage logbooks once the new data sheets are implemented.
Your response is inadequate because it does not adequately address major deficiencies in your laboratory system. Your response does not address your oversight of data integrity including, but not limited to, improving your quality assurance function. Your response does not provide a comprehensive retrospective risk assessment or complete testing of all potentially impacted drug products within expiry and fails to adequately assess and mitigate the risk to consumers.
Reliability of data is fundamentally compromised when there is a failure to record data or to maintain complete and accurate records of test results. Furthermore, the lack of reliable data compromises the ability of your QU to exercise its function of ensuring compliance to applicable standards.
Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. See FDA's guidance document Data Integrity and Compliance With Drug CGMP: Questions and Answers for guidance on establishing and following CGMP compliant data integrity practices at https://www.fda.gov/media/119267/download.
We strongly recommend that you retain an independent third-party qualified consultant to assist in your remediation. In response to this letter, provide:
* A comprehensive investigation into the extent of the inaccuracies in data records and reporting. Your investigation should include:
- A detailed investigation protocol and methodology; a summary of all laboratories, manufacturing operations, and systems to be covered by the assessment; and a justification for any part of your operation that you propose to exclude.
- Interviews of current and former employees to identify the nature, scope, and root cause of data inaccuracies. We recommend that these interviews be conducted by a qualified third party.
- An assessment of the extent of data integrity deficiencies at your facility. Identify omissions, alterations, deletions, record destruction, non-contemporaneous record completion, and other deficiencies. Describe all parts of your facility's operations in which you discovered data integrity lapses.
- A comprehensive retrospective evaluation of the nature of all data integrity deficiencies. We recommend that a qualified third party with specific expertise in the area where potential breaches were identified should evaluate all data integrity lapses.
* A current risk assessment of the potential effects of the observed failures on the quality of your drugs. Your assessment should include analyses of the risks to patients caused by the release of drugs affected by a lapse of data integrity and analyses of the risks posed by ongoing operations.
* A management strategy for your firm that includes the details of your global corrective action and preventive action plan. Your strategy should include:
- A detailed corrective action plan that describes how you intend to ensure the reliability and completeness of all the data you generate including analytical data, manufacturing records, and all data submitted to FDA.
- A comprehensive description of the root causes of your data integrity lapses including evidence that the scope and depth of the current action plan is commensurate with the findings of the investigation and risk assessment. Indicate whether individuals responsible for data integrity lapses remain able to influence CGMP-related or drug application data at your firm.
- Interim measures describing the actions you have taken or will take to protect patients and to ensure the quality of your drugs, such as notifying your customers, recalling product, conducting additional testing, adding lots to your stability programs to assure stability, drug application actions, and enhanced complaint monitoring.
- Long-term measures describing any remediation efforts and enhancements to procedures, processes, methods, controls, systems, management oversight, and human resources (e.g., training, staffing improvements) designed to ensure the integrity of your company's data.
- A commitment to have a qualified consultant conduct extensive annual audits, for at least two years, to assist in evaluating CAPA effectiveness after you have executed your data integrity remediation protocol.
- Inform FDA if you will be hiring a Chief Integrity Officer who is fully empowered to receive anonymous complaints from employees reporting data integrity concerns and with the authority to ensure any potential breach is promptly investigated (by independent quality assurance function, along with expertise from outside entities whenever needed).
- A status report for any of the above activities already underway or completed.
3. Your firm failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)).
You failed to demonstrate that your cleaning practices are adequate to remove potential contaminants and to prevent drug product carry over in shared equipment used to manufacture your OTC drug products.
For example, your cleaning validation program for the non-dedicated Unit (b)(4) Line (b)(4) relied exclusively on the visual inspection of (b)(4) to determine adequate cleaning. Your cleaning validation program lacked scientifically determined maximum allowable carryover limits, quantitative residue testing, or direct surface sampling of difficult-to-clean areas. In addition, you did not perform any cleaning validation for Unit (b)(4) Line (b)(4) despite using it to manufacture at least (b)(4) different OTC drug products.
In your response, you acknowledge the deficiencies in your cleaning validation program. You commit to enhancing your cleaning validation program by developing validated analytical methods, establishing carryover limits, implementing direct surface swab sampling, and revalidating the cleaning process. You stated that Line (b)(4) is now dedicated to a (b)(4) drug product, and you are conducting a limited retrospective quality review by testing only (b)(4) samples for potential cross-contamination.
Your response is inadequate because it does not address the interim controls you will implement to mitigate the risk of cross-contamination during your remediation period. Additionally, testing only (b)(4) samples from the (b)(4) batches manufactured on Line (b)(4) is statistically insufficient to assess the potential for cross-contamination. Further, your response also does not include a retrospective review of all drug products released to the U.S. market and within expiry for potential cross-contamination resulting from the use of a non-validated cleaning process on non-dedicated equipment.
Inadequate removal of active ingredients and drug product residues from surfaces of non-dedicated manufacturing equipment can lead to contamination of drug products subsequently manufactured on that equipment.
In response to this letter, provide:
* Your CAPA plan to implement routine, vigilant operations management oversight of facilities and equipment. This plan should incorporate oversight from a qualified independent consultant and ensure, among other things, prompt detection of equipment/facilities performance issues, effective execution of repairs, adherence to appropriate preventive maintenance schedules, timely technological upgrades to the equipment/facility infrastructure, and improved systems for ongoing management review. Your plan should also ensure that appropriate actions are taken throughout the company network.
* A comprehensive, independent retrospective assessment of your cleaning effectiveness to evaluate the scope of cross-contamination hazards. Include the identity of residues, other manufacturing equipment that may have been improperly cleaned, and an assessment whether cross-contaminated drug products may have been released for distribution. The assessment should identify any inadequacies of cleaning procedures and practices, and encompass each piece of manufacturing equipment used to manufacture more than one drug product.
* Appropriate improvements to your cleaning validation program, with special emphasis on incorporating conditions identified as worst case in your drug manufacturing operation. This should include but not be limited to identification and evaluation of all worst-case:
- drugs with higher toxicities
- drugs with higher drug potencies
- drugs of lower solubility in their cleaning solvents
- drugs with characteristics that make them difficult to clean
- swabbing locations for areas that are most difficult to clean
- maximum hold times before cleaning
* In addition, describe the steps that must be taken in your change management system before introduction of new manufacturing equipment or a new drug product.
* A summary of updated SOPs that ensure an appropriate program is in place for verification and validation of cleaning procedures for drug products, processes, and equipment.
4. 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, and your firm's quality control unit did not review and approve those procedures, including any changes (21 CFR 211.100(a)).
You failed to validate your manufacturing process for your OTC drug products. During the inspection, you stated that you had not performed process validation for (b)(4) of the (b)(4) drug products you manufacture on Unit (b)(4) lines. You also stated you had not performed process validation for (b)(4) of the (b)(4) drug products you manufacture on Unit (b)(4) lines.
In your response, you acknowledge the lack of process validation for most of your drug products and commit to preparing process validation plans and protocols using a campaign-based approach.
Your response is inadequate because it does not provide a schedule or timeframes for completing process validation activities for each of your drug products. Furthermore, your response lacks an interim plan, such as enhanced finished drug product testing, for any drugs manufactured and distributed before these validation activities are completed to ensure you produce drug products of acceptable quality. You also did not provide drug product impact assessments for U.S. distributed drug products within expiry and ongoing manufacturing.
Process validation evaluates the soundness of design and state of control of a process throughout its lifecycle. Each significant stage of a manufacturing process must be designed appropriately and assure the quality of raw material inputs, in-process materials, and finished drugs. Process qualification studies include intensive monitoring and testing throughout each significant process stage to characterize intra-batch variation and evaluate batches to determine whether an initial state of control has been established.
Successful process qualification studies are necessary before commercial distribution. Thereafter, ongoing vigilant oversight of process performance and drug product quality is necessary to ensure you maintain a stable manufacturing operation throughout the drug product lifecycle. See FDA's guidance for industry, Process Validation: General Principles and Practices, for general principles and approaches that the FDA considers appropriate elements of process validation at
https://www.fda.gov/media/71021/download.
In response to this letter, provide:
* A detailed summary of your validation program for ensuring a state of control throughout the product lifecycle, along with associated procedures. Describe your program for process performance qualification and ongoing monitoring of both intra-batch and inter-batch variation to ensure a continuing state of control.
* A timeline for performing process performance qualification for each of your marketed drug products.
* Process performance protocols, and written procedures for qualification of equipment and facilities.
* A detailed program for designing, validating, maintaining, controlling, and monitoring each of your manufacturing processes that includes vigilant monitoring of intra-batch and inter-batch variation to ensure an ongoing state of control. Also, include your program for qualification of your equipment and facility.
Drug Recall
On May 13, 2026, FDA held a teleconference with you recommending you consider removing batches of all (b)(4) currently in distribution from the U.S. market.
On June 2, 2026, you issued a voluntary recall of all (b)(4), and (b)(4) due to due to systemic quality failures at your facility. To date, you have not recalled your (b)(4) drug products.
CGMP Consultant Recommended
Based upon the nature of the violations we identified at your firm, you should engage a consultant qualified 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 of your entire operation for CGMP compliance and evaluate the completion and efficacy of your corrective actions and preventive actions 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.
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.
FDA placed all drugs and drug products offered for import into the United States from your firm on Import Alert 66-40 on June 5, 2026.
Correct any violations promptly. 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 any violations.
Failure to address any violations may also result in the FDA continuing to refuse admission of articles manufactured at Dabur India Limited, at Survey No. 225/4/1, Village: Saily, Silvassa, Dadra and Nagar Haveli and Daman and Diu, into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Articles under this authority that appear to be adulterated may be detained or refused admission, in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B).
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. 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 3001413302 and ATTN: Rokhsana Safaai-Jazi.
Sincerely,
/S/ Francis Godwin, Director, Office of Manufacturing Quality, Office of Compliance, Center for Drug Evaluation and Research
* * *
Original text here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/dabur-india-limited-728828-07242026
* * *
Recipient: Mr. Mohit Malhotra, Chief Executive Officer, Dabur India Limited, Dabur Corporate Office, Kaushambi, Sahibabad, Ghaziabad 201010, India
Issuing Office: Center for Drug Evaluation and Research (CDER), United States
Warning Letter 320-26-105
Dear Mr. Malhotra:
The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Dabur India Limited, ... Show Full Article WASHINGTON, Aug. 5 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Dabur India Limited from its Center for Drug Evaluation and Research: * * * Recipient: Mr. Mohit Malhotra, Chief Executive Officer, Dabur India Limited, Dabur Corporate Office, Kaushambi, Sahibabad, Ghaziabad 201010, India Issuing Office: Center for Drug Evaluation and Research (CDER), United States Warning Letter 320-26-105 Dear Mr. Malhotra: The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Dabur India Limited,FEI 3001413302, at Survey No. 225/4/1, Village: Saily, Silvassa, Dadra and Nagar Haveli and Daman and Diu, from January 12 to 16, 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 February 4, 2026 response to our Form FDA 483 in detail.
During our inspection, our investigator observed specific violations including, but not limited to, the following.
1. Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products and the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated (21 CFR 211.22(a)).
Your firm manufactures over-the-counter drug products including (b)(4) and (b)(4). Your quality unit (QU) failed to exercise its authority and responsibilities over your drug manufacturing operations, including ensuring the integrity of your production records.
During the inspection, our investigator requested the equipment usage logbook for Unit (b)(4), Line (b)(4), which your management stated was dedicated exclusively to (b)(4) manufacturing. Your firm delayed providing this record for several days. When your firm finally produced the logbook, it appeared to have been newly created. Subsequently, our investigator discovered the original logbook in the document room. A comparison of the two logbooks revealed that the version provided to our investigator was falsified. The fraudulent logbook listed entries only for (b)(4). It deliberately omitted multiple U.S. marketed OTC drug products that were documented in the original logbook, including (b)(4).
Furthermore, our investigator identified multiple discrepancies between the source data in your analytical data books and the final values reported in your batch manufacturing records or certificates of analysis. For multiple batches of (b)(4) and (b)(4), the reported values for quality attributes such as residue on ignition, melting range, pH, and viscosity did not match the original data. While these inaccuracies did not involve out-of-specification results, your QU signed off on these records without ensuring the consistency and accuracy of the data.
In your response, you acknowledge these deficiencies, attributing the falsified logbook to "inadequate documentation controls, insufficient oversight, and lack of robust governance." You attributed other data inaccuracies to your transcription practices and inadequate resources within your QU for proper review. You state that you trained personnel on data integrity and committed to revising procedures and reviewing only the (b)(4) of data for similar transcription errors. You also commit to sending "(b)(4) samples of impacted drug product including (b)(4)" to a contract testing laboratory.
Your response is inadequate because it fails to address the severity of the observed data integrity failures. Your proposed corrective actions address the data integrity breaches as isolated procedural gaps rather than as evidence of a systemic breakdown in QU oversight and a deficient quality culture. Your response does not address the fundamental failure of your QU to ensure the integrity and completeness of all data related to your drug manufacturing operations, nor does it include an adequate assessment of the potential impact on the quality of drug products already distributed to the U.S. market. Furthermore, your response lacks a sufficient comprehensive evaluation of your QU's capabilities to fulfill all required quality-related functions.
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.
In response to this letter, provide:
* A comprehensive assessment of documentation systems used throughout your manufacturing and laboratory operations to determine where documentation practices are insufficient. Include a detailed corrective action and preventive action (CAPA) plan that comprehensively remediates your firm's documentation practices to ensure you retain attributable, legible, complete, original, accurate, contemporaneous records throughout your operation.
* A comprehensive assessment and remediation plan to ensure your QU is given the authority and resources to effectively function. The assessment should also include, but not be limited to:
- A determination of whether procedures used by your firm are robust and appropriate
- Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices
- A complete and final review of each batch and its related information before the QU disposition decision
- Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products.
2. Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards (21 CFR 211.194(a)).
Your laboratory records did not include complete data to support the analyses performed. For example, your analytical notebooks documented approximately (b)(4) microbiology plates for finished drug products and approximately (b)(4) media plates for testing (b)(4) samples as incubated, but the plates were physically absent from incubators with no documented explanation about their whereabouts or disposal. In addition, during the inspection you could not produce the test procedures, analytical workbooks, or test data sheets to support the reported certificate of analysis results for approximately (b)(4) batches of U.S. marketed drug products. You also failed to make the required entries in your equipment logbooks to reflect the use of multiple instruments for the specific batch release tests performed.
In your response, you indicate that a microbiologist inadvertently discarded the missing microbiological plates due to lack of training. You state that you retrained the microbiologist, re-analyzed the missing finished drug product plates, and introduced a new controlled logbook to improve sample traceability.
Regarding the batches released without supporting analytical records, you commit to sending samples for several of the batches to a contract laboratory for retrospective testing and to implementing formal test data sheets for future data recording. Further, you state that you have retrained the personnel responsible for failing to document instrument usage and that you will discontinue the use of separate equipment usage logbooks once the new data sheets are implemented.
Your response is inadequate because it does not adequately address major deficiencies in your laboratory system. Your response does not address your oversight of data integrity including, but not limited to, improving your quality assurance function. Your response does not provide a comprehensive retrospective risk assessment or complete testing of all potentially impacted drug products within expiry and fails to adequately assess and mitigate the risk to consumers.
Reliability of data is fundamentally compromised when there is a failure to record data or to maintain complete and accurate records of test results. Furthermore, the lack of reliable data compromises the ability of your QU to exercise its function of ensuring compliance to applicable standards.
Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. See FDA's guidance document Data Integrity and Compliance With Drug CGMP: Questions and Answers for guidance on establishing and following CGMP compliant data integrity practices at https://www.fda.gov/media/119267/download.
We strongly recommend that you retain an independent third-party qualified consultant to assist in your remediation. In response to this letter, provide:
* A comprehensive investigation into the extent of the inaccuracies in data records and reporting. Your investigation should include:
- A detailed investigation protocol and methodology; a summary of all laboratories, manufacturing operations, and systems to be covered by the assessment; and a justification for any part of your operation that you propose to exclude.
- Interviews of current and former employees to identify the nature, scope, and root cause of data inaccuracies. We recommend that these interviews be conducted by a qualified third party.
- An assessment of the extent of data integrity deficiencies at your facility. Identify omissions, alterations, deletions, record destruction, non-contemporaneous record completion, and other deficiencies. Describe all parts of your facility's operations in which you discovered data integrity lapses.
- A comprehensive retrospective evaluation of the nature of all data integrity deficiencies. We recommend that a qualified third party with specific expertise in the area where potential breaches were identified should evaluate all data integrity lapses.
* A current risk assessment of the potential effects of the observed failures on the quality of your drugs. Your assessment should include analyses of the risks to patients caused by the release of drugs affected by a lapse of data integrity and analyses of the risks posed by ongoing operations.
* A management strategy for your firm that includes the details of your global corrective action and preventive action plan. Your strategy should include:
- A detailed corrective action plan that describes how you intend to ensure the reliability and completeness of all the data you generate including analytical data, manufacturing records, and all data submitted to FDA.
- A comprehensive description of the root causes of your data integrity lapses including evidence that the scope and depth of the current action plan is commensurate with the findings of the investigation and risk assessment. Indicate whether individuals responsible for data integrity lapses remain able to influence CGMP-related or drug application data at your firm.
- Interim measures describing the actions you have taken or will take to protect patients and to ensure the quality of your drugs, such as notifying your customers, recalling product, conducting additional testing, adding lots to your stability programs to assure stability, drug application actions, and enhanced complaint monitoring.
- Long-term measures describing any remediation efforts and enhancements to procedures, processes, methods, controls, systems, management oversight, and human resources (e.g., training, staffing improvements) designed to ensure the integrity of your company's data.
- A commitment to have a qualified consultant conduct extensive annual audits, for at least two years, to assist in evaluating CAPA effectiveness after you have executed your data integrity remediation protocol.
- Inform FDA if you will be hiring a Chief Integrity Officer who is fully empowered to receive anonymous complaints from employees reporting data integrity concerns and with the authority to ensure any potential breach is promptly investigated (by independent quality assurance function, along with expertise from outside entities whenever needed).
- A status report for any of the above activities already underway or completed.
3. Your firm failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)).
You failed to demonstrate that your cleaning practices are adequate to remove potential contaminants and to prevent drug product carry over in shared equipment used to manufacture your OTC drug products.
For example, your cleaning validation program for the non-dedicated Unit (b)(4) Line (b)(4) relied exclusively on the visual inspection of (b)(4) to determine adequate cleaning. Your cleaning validation program lacked scientifically determined maximum allowable carryover limits, quantitative residue testing, or direct surface sampling of difficult-to-clean areas. In addition, you did not perform any cleaning validation for Unit (b)(4) Line (b)(4) despite using it to manufacture at least (b)(4) different OTC drug products.
In your response, you acknowledge the deficiencies in your cleaning validation program. You commit to enhancing your cleaning validation program by developing validated analytical methods, establishing carryover limits, implementing direct surface swab sampling, and revalidating the cleaning process. You stated that Line (b)(4) is now dedicated to a (b)(4) drug product, and you are conducting a limited retrospective quality review by testing only (b)(4) samples for potential cross-contamination.
Your response is inadequate because it does not address the interim controls you will implement to mitigate the risk of cross-contamination during your remediation period. Additionally, testing only (b)(4) samples from the (b)(4) batches manufactured on Line (b)(4) is statistically insufficient to assess the potential for cross-contamination. Further, your response also does not include a retrospective review of all drug products released to the U.S. market and within expiry for potential cross-contamination resulting from the use of a non-validated cleaning process on non-dedicated equipment.
Inadequate removal of active ingredients and drug product residues from surfaces of non-dedicated manufacturing equipment can lead to contamination of drug products subsequently manufactured on that equipment.
In response to this letter, provide:
* Your CAPA plan to implement routine, vigilant operations management oversight of facilities and equipment. This plan should incorporate oversight from a qualified independent consultant and ensure, among other things, prompt detection of equipment/facilities performance issues, effective execution of repairs, adherence to appropriate preventive maintenance schedules, timely technological upgrades to the equipment/facility infrastructure, and improved systems for ongoing management review. Your plan should also ensure that appropriate actions are taken throughout the company network.
* A comprehensive, independent retrospective assessment of your cleaning effectiveness to evaluate the scope of cross-contamination hazards. Include the identity of residues, other manufacturing equipment that may have been improperly cleaned, and an assessment whether cross-contaminated drug products may have been released for distribution. The assessment should identify any inadequacies of cleaning procedures and practices, and encompass each piece of manufacturing equipment used to manufacture more than one drug product.
* Appropriate improvements to your cleaning validation program, with special emphasis on incorporating conditions identified as worst case in your drug manufacturing operation. This should include but not be limited to identification and evaluation of all worst-case:
- drugs with higher toxicities
- drugs with higher drug potencies
- drugs of lower solubility in their cleaning solvents
- drugs with characteristics that make them difficult to clean
- swabbing locations for areas that are most difficult to clean
- maximum hold times before cleaning
* In addition, describe the steps that must be taken in your change management system before introduction of new manufacturing equipment or a new drug product.
* A summary of updated SOPs that ensure an appropriate program is in place for verification and validation of cleaning procedures for drug products, processes, and equipment.
4. 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, and your firm's quality control unit did not review and approve those procedures, including any changes (21 CFR 211.100(a)).
You failed to validate your manufacturing process for your OTC drug products. During the inspection, you stated that you had not performed process validation for (b)(4) of the (b)(4) drug products you manufacture on Unit (b)(4) lines. You also stated you had not performed process validation for (b)(4) of the (b)(4) drug products you manufacture on Unit (b)(4) lines.
In your response, you acknowledge the lack of process validation for most of your drug products and commit to preparing process validation plans and protocols using a campaign-based approach.
Your response is inadequate because it does not provide a schedule or timeframes for completing process validation activities for each of your drug products. Furthermore, your response lacks an interim plan, such as enhanced finished drug product testing, for any drugs manufactured and distributed before these validation activities are completed to ensure you produce drug products of acceptable quality. You also did not provide drug product impact assessments for U.S. distributed drug products within expiry and ongoing manufacturing.
Process validation evaluates the soundness of design and state of control of a process throughout its lifecycle. Each significant stage of a manufacturing process must be designed appropriately and assure the quality of raw material inputs, in-process materials, and finished drugs. Process qualification studies include intensive monitoring and testing throughout each significant process stage to characterize intra-batch variation and evaluate batches to determine whether an initial state of control has been established.
Successful process qualification studies are necessary before commercial distribution. Thereafter, ongoing vigilant oversight of process performance and drug product quality is necessary to ensure you maintain a stable manufacturing operation throughout the drug product lifecycle. See FDA's guidance for industry, Process Validation: General Principles and Practices, for general principles and approaches that the FDA considers appropriate elements of process validation at
https://www.fda.gov/media/71021/download.
In response to this letter, provide:
* A detailed summary of your validation program for ensuring a state of control throughout the product lifecycle, along with associated procedures. Describe your program for process performance qualification and ongoing monitoring of both intra-batch and inter-batch variation to ensure a continuing state of control.
* A timeline for performing process performance qualification for each of your marketed drug products.
* Process performance protocols, and written procedures for qualification of equipment and facilities.
* A detailed program for designing, validating, maintaining, controlling, and monitoring each of your manufacturing processes that includes vigilant monitoring of intra-batch and inter-batch variation to ensure an ongoing state of control. Also, include your program for qualification of your equipment and facility.
Drug Recall
On May 13, 2026, FDA held a teleconference with you recommending you consider removing batches of all (b)(4) currently in distribution from the U.S. market.
On June 2, 2026, you issued a voluntary recall of all (b)(4), and (b)(4) due to due to systemic quality failures at your facility. To date, you have not recalled your (b)(4) drug products.
CGMP Consultant Recommended
Based upon the nature of the violations we identified at your firm, you should engage a consultant qualified 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 of your entire operation for CGMP compliance and evaluate the completion and efficacy of your corrective actions and preventive actions 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.
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.
FDA placed all drugs and drug products offered for import into the United States from your firm on Import Alert 66-40 on June 5, 2026.
Correct any violations promptly. 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 any violations.
Failure to address any violations may also result in the FDA continuing to refuse admission of articles manufactured at Dabur India Limited, at Survey No. 225/4/1, Village: Saily, Silvassa, Dadra and Nagar Haveli and Daman and Diu, into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Articles under this authority that appear to be adulterated may be detained or refused admission, in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B).
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. 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 3001413302 and ATTN: Rokhsana Safaai-Jazi.
Sincerely,
/S/ Francis Godwin, Director, Office of Manufacturing Quality, Office of Compliance, Center for Drug Evaluation and Research
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Original text here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/dabur-india-limited-728828-07242026
FCC Consumer & Governmental Affairs Bureau Issues Public Notice: Announcement of Tribal Workshop in Albuquerque, N.M., Aug. 20-21, 2026
WASHINGTON, Aug. 5 -- The Federal Communications Commission Consumer and Governmental Affairs Bureau issued the following public notice (Docket No. DA 26-819):
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By this Public Notice, the Federal Communications Commission (FCC) announces a workshop for Tribal Nations and Native Hawaiian Organizations (NHOs) designed to provide information on a broad range of FCC initiatives that support the deployment of communications infrastructure and services nationwide, including on Tribal lands. The workshop's duration is a day and a half. The first day will cover important broadband topics, including ... Show Full Article WASHINGTON, Aug. 5 -- The Federal Communications Commission Consumer and Governmental Affairs Bureau issued the following public notice (Docket No. DA 26-819): * * * By this Public Notice, the Federal Communications Commission (FCC) announces a workshop for Tribal Nations and Native Hawaiian Organizations (NHOs) designed to provide information on a broad range of FCC initiatives that support the deployment of communications infrastructure and services nationwide, including on Tribal lands. The workshop's duration is a day and a half. The first day will cover important broadband topics, includinga multi-agency discussion on federal broadband funding with the National Telecommunications and Information Administration and Rural Utilities Service. The second day will offer a hands-on training opportunity by FCC Broadband Data Task Force on the FCC's Broadband Data Collection (BDC) and National Broadband Map, with a focus on how to file broadband data and challenges for the BDC.
* Date and Time: Thursday, August 20, 2026, at 9:00 a.m. - 4:00 p.m. MDT and Friday, August 21, 2026, at 9:00 a.m. - 1:00 p.m. MDT
* Where: National Indian Programs Training Center (NIPTC), 1011 Indian School Road, NW, Suite 254, Albuquerque, NM 87104
* Registration: The workshop is free, but registration is required. To pre-register, please email your name, title, Tribal affiliation, and contact information, with the subject line, "August Workshop," to Native@fcc.gov.
* Who should consider attending? Tribal government leaders, Tribal telecommunications and IT managers, Tribal government and community planners and managers, Tribal enterprise specialists, Tribal broadband providers, and Tribal Geographic Information System (GIS) staff members should consider attending.
* Questions? Any questions about the workshop may be directed to the Office of Native Affairs and Policy: Native@fcc.gov.
The agenda and other meeting materials will be posted to the FCC's Office of Native Affairs and Policy webpage when available.
In conjunction with the workshop, on the afternoon of Wednesday, August 19, 2026, the FCC Broadband Data Task Force is offering Office Hours for tribal entities with questions about the FCC's Broadband Serviceable Location Fabric and to provide hands on GIS support. You may also indicate interest in the Broadband Data Task Force's Office Hours when registering for the workshop.
GIS Software Training Opportunity
The Bureau of Indian Affairs Office of Trust Services will also be providing in-person GIS training at the NIPTC on August 18-19. The two-day, hands-on training course provides a practical introduction to both ArcGIS Pro and ArcGIS Online, equipping participants with the foundational skills needed to manage, analyze, collect, and share geospatial data. For more information, please click here: https://www.bia.gov/events/msu-arcgis-pro-and-arcgis-online-fundamentals-two-day-hands-training.
Reasonable Accommodations
Reasonable accommodations for people with disabilities are available upon request by sending an e-mail to: FCC504@fcc.gov or calling the Consumer and Governmental Affairs Bureau at 202-418-0530 (voice). Include a description of the accommodation you will need and tell us how to contact you if we need more information. Please make your request as early as possible as we may be unable to fulfill last-minute requests.
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Original text here: https://docs.fcc.gov/public/attachments/DA-26-819A1.pdf
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By this Public Notice, the Federal Communications Commission (FCC) announces a workshop for Tribal Nations and Native Hawaiian Organizations (NHOs) designed to provide information on a broad range of FCC initiatives that support the deployment of communications infrastructure and services nationwide, including on Tribal lands. The workshop's duration is a day and a half. The first day will cover important broadband topics, including ... Show Full Article WASHINGTON, Aug. 5 -- The Federal Communications Commission Consumer and Governmental Affairs Bureau issued the following public notice (Docket No. DA 26-819): * * * By this Public Notice, the Federal Communications Commission (FCC) announces a workshop for Tribal Nations and Native Hawaiian Organizations (NHOs) designed to provide information on a broad range of FCC initiatives that support the deployment of communications infrastructure and services nationwide, including on Tribal lands. The workshop's duration is a day and a half. The first day will cover important broadband topics, includinga multi-agency discussion on federal broadband funding with the National Telecommunications and Information Administration and Rural Utilities Service. The second day will offer a hands-on training opportunity by FCC Broadband Data Task Force on the FCC's Broadband Data Collection (BDC) and National Broadband Map, with a focus on how to file broadband data and challenges for the BDC.
* Date and Time: Thursday, August 20, 2026, at 9:00 a.m. - 4:00 p.m. MDT and Friday, August 21, 2026, at 9:00 a.m. - 1:00 p.m. MDT
* Where: National Indian Programs Training Center (NIPTC), 1011 Indian School Road, NW, Suite 254, Albuquerque, NM 87104
* Registration: The workshop is free, but registration is required. To pre-register, please email your name, title, Tribal affiliation, and contact information, with the subject line, "August Workshop," to Native@fcc.gov.
* Who should consider attending? Tribal government leaders, Tribal telecommunications and IT managers, Tribal government and community planners and managers, Tribal enterprise specialists, Tribal broadband providers, and Tribal Geographic Information System (GIS) staff members should consider attending.
* Questions? Any questions about the workshop may be directed to the Office of Native Affairs and Policy: Native@fcc.gov.
The agenda and other meeting materials will be posted to the FCC's Office of Native Affairs and Policy webpage when available.
In conjunction with the workshop, on the afternoon of Wednesday, August 19, 2026, the FCC Broadband Data Task Force is offering Office Hours for tribal entities with questions about the FCC's Broadband Serviceable Location Fabric and to provide hands on GIS support. You may also indicate interest in the Broadband Data Task Force's Office Hours when registering for the workshop.
GIS Software Training Opportunity
The Bureau of Indian Affairs Office of Trust Services will also be providing in-person GIS training at the NIPTC on August 18-19. The two-day, hands-on training course provides a practical introduction to both ArcGIS Pro and ArcGIS Online, equipping participants with the foundational skills needed to manage, analyze, collect, and share geospatial data. For more information, please click here: https://www.bia.gov/events/msu-arcgis-pro-and-arcgis-online-fundamentals-two-day-hands-training.
Reasonable Accommodations
Reasonable accommodations for people with disabilities are available upon request by sending an e-mail to: FCC504@fcc.gov or calling the Consumer and Governmental Affairs Bureau at 202-418-0530 (voice). Include a description of the accommodation you will need and tell us how to contact you if we need more information. Please make your request as early as possible as we may be unable to fulfill last-minute requests.
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Original text here: https://docs.fcc.gov/public/attachments/DA-26-819A1.pdf
DOD IG: Project Announcement: Summary External Peer Review of the Air Force Audit Agency
WASHINGTON, Aug. 5 (TNSLrpt) -- The Defense Inspector General issued the following report (No. D2026-DEV0SO-0118.000) on July 20, 2026, entitled "Project Announcement: Summary External Peer Review of the Air Force Audit Agency."
Here are excerpts:
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The purpose of this memorandum is to notify you that the DoW Office of Inspector General is initiating the subject external peer review.
The Inspector General Act of 1978, as amended, states that the DoD OIG will conduct, or approve arrangements for the conduct of, external peer reviews of DoD agencies in accordance with the Generally Accepted ... Show Full Article WASHINGTON, Aug. 5 (TNSLrpt) -- The Defense Inspector General issued the following report (No. D2026-DEV0SO-0118.000) on July 20, 2026, entitled "Project Announcement: Summary External Peer Review of the Air Force Audit Agency." Here are excerpts: * * * The purpose of this memorandum is to notify you that the DoW Office of Inspector General is initiating the subject external peer review. The Inspector General Act of 1978, as amended, states that the DoD OIG will conduct, or approve arrangements for the conduct of, external peer reviews of DoD agencies in accordance with the Generally AcceptedGovernment Auditing Standards (GAGAS). GAGAS requires that an audit organization performing engagements in accordance with GAGAS undergo an external peer review every 3 years by an organization that is independent of the organization being reviewed.
The objective of this external peer review is to provide oversight of the Naval Audit Service's peer review of Air Force Audit Agency non-Special Access Program (SAP) projects for the 3-year period that ended on December 31, 2025. In addition, we will combine the results of the Naval Audit Service's external peer review of Air Force Audit Agency non-SAP projects with our results of Air Force Audit Agency SAP projects to provide a summary opinion on the Air Force Audit Agency's system of quality control for the 3-year period ended
December 31, 2025. We plan to perform this external peer review in accordance with the Council of the Inspectors General on Integrity and Efficiency, "Guide for Conducting External Peer Reviews of the Audit Organizations of Federal Offices of Inspector General." We request that you designate two points of contact for this external peer review within 5 days of this memorandum. One point of contact should be a Government employee--a GS-15, pay band equivalent, or military equivalent--who is knowledgeable of external peer review process related to the objective. The second point of contact should be a member of the Senior Executive Service or a General/Flag Officer who is familiar with the external peer review process and could serve as a point of engagement with DoW Office of Inspector General senior leaders, if necessary
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The report is posted at: https://media.defense.gov/2026/Jul/23/2003966076/-1/-1/1/D2026-DEV0SO-0118.000_REDACTED_FINAL.PDF
Here are excerpts:
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The purpose of this memorandum is to notify you that the DoW Office of Inspector General is initiating the subject external peer review.
The Inspector General Act of 1978, as amended, states that the DoD OIG will conduct, or approve arrangements for the conduct of, external peer reviews of DoD agencies in accordance with the Generally Accepted ... Show Full Article WASHINGTON, Aug. 5 (TNSLrpt) -- The Defense Inspector General issued the following report (No. D2026-DEV0SO-0118.000) on July 20, 2026, entitled "Project Announcement: Summary External Peer Review of the Air Force Audit Agency." Here are excerpts: * * * The purpose of this memorandum is to notify you that the DoW Office of Inspector General is initiating the subject external peer review. The Inspector General Act of 1978, as amended, states that the DoD OIG will conduct, or approve arrangements for the conduct of, external peer reviews of DoD agencies in accordance with the Generally AcceptedGovernment Auditing Standards (GAGAS). GAGAS requires that an audit organization performing engagements in accordance with GAGAS undergo an external peer review every 3 years by an organization that is independent of the organization being reviewed.
The objective of this external peer review is to provide oversight of the Naval Audit Service's peer review of Air Force Audit Agency non-Special Access Program (SAP) projects for the 3-year period that ended on December 31, 2025. In addition, we will combine the results of the Naval Audit Service's external peer review of Air Force Audit Agency non-SAP projects with our results of Air Force Audit Agency SAP projects to provide a summary opinion on the Air Force Audit Agency's system of quality control for the 3-year period ended
December 31, 2025. We plan to perform this external peer review in accordance with the Council of the Inspectors General on Integrity and Efficiency, "Guide for Conducting External Peer Reviews of the Audit Organizations of Federal Offices of Inspector General." We request that you designate two points of contact for this external peer review within 5 days of this memorandum. One point of contact should be a Government employee--a GS-15, pay band equivalent, or military equivalent--who is knowledgeable of external peer review process related to the objective. The second point of contact should be a member of the Senior Executive Service or a General/Flag Officer who is familiar with the external peer review process and could serve as a point of engagement with DoW Office of Inspector General senior leaders, if necessary
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The report is posted at: https://media.defense.gov/2026/Jul/23/2003966076/-1/-1/1/D2026-DEV0SO-0118.000_REDACTED_FINAL.PDF