Federal Executive Branch
Here's a look at documents from the U.S. Executive Branch
Featured Stories
Secretary of State Rubio Issues Statement on Tonga National Day
WASHINGTON, Nov. 4 -- The U.S. State Department issued the following news release:
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Tonga National Day
Press Statement
Marco Rubio, Secretary of State
November 3, 2026
On behalf of the United States of America, I wish all Tongans a joyous celebration of your Constitution Day.
The past year has raised the U.S.-Tonga relationship to new heights. From cooperation on advancing marine scientific research to joint investment in fuel security and digital infrastructure, the United States and the Kingdom of Tonga continue to build on more than a century of friendship.
Today, we celebrate the ... Show Full Article WASHINGTON, Nov. 4 -- The U.S. State Department issued the following news release: * * * Tonga National Day Press Statement Marco Rubio, Secretary of State November 3, 2026 On behalf of the United States of America, I wish all Tongans a joyous celebration of your Constitution Day. The past year has raised the U.S.-Tonga relationship to new heights. From cooperation on advancing marine scientific research to joint investment in fuel security and digital infrastructure, the United States and the Kingdom of Tonga continue to build on more than a century of friendship. Today, we celebrate thestrength and heritage of the Tongan people, and we look forward to another year of close collaboration as partners.
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Original text here: https://www.state.gov/releases/office-of-the-spokesman/2026/11/tonga-national-day-2/
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Tonga National Day
Press Statement
Marco Rubio, Secretary of State
November 3, 2026
On behalf of the United States of America, I wish all Tongans a joyous celebration of your Constitution Day.
The past year has raised the U.S.-Tonga relationship to new heights. From cooperation on advancing marine scientific research to joint investment in fuel security and digital infrastructure, the United States and the Kingdom of Tonga continue to build on more than a century of friendship.
Today, we celebrate the ... Show Full Article WASHINGTON, Nov. 4 -- The U.S. State Department issued the following news release: * * * Tonga National Day Press Statement Marco Rubio, Secretary of State November 3, 2026 On behalf of the United States of America, I wish all Tongans a joyous celebration of your Constitution Day. The past year has raised the U.S.-Tonga relationship to new heights. From cooperation on advancing marine scientific research to joint investment in fuel security and digital infrastructure, the United States and the Kingdom of Tonga continue to build on more than a century of friendship. Today, we celebrate thestrength and heritage of the Tongan people, and we look forward to another year of close collaboration as partners.
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Original text here: https://www.state.gov/releases/office-of-the-spokesman/2026/11/tonga-national-day-2/
SEC Obtains Final Judgments as to The Movie Company and Its CEO in Connection With Alleged Offering Fraud
WASHINGTON, Nov. 4 (TNSdock) -- The Securities and Exchange Commission issued the following litigation release:
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Securities and Exchange Commission v. The Movie Studio, Inc. et al., Civil Action No. 0:21-cv-61686-DPG (S.D. Fla. filed Aug. 13, 2021)
On October 15, 2026, the United States District Court for the Southern District of Florida entered final judgments as to The Movie Studio, Inc., a Florida-based movie company, and its President and CEO, Gordon Scott Venters, in connection with charges that they made material misrepresentations to investors in an unregistered securities offering ... Show Full Article WASHINGTON, Nov. 4 (TNSdock) -- The Securities and Exchange Commission issued the following litigation release: * * * Securities and Exchange Commission v. The Movie Studio, Inc. et al., Civil Action No. 0:21-cv-61686-DPG (S.D. Fla. filed Aug. 13, 2021) On October 15, 2026, the United States District Court for the Southern District of Florida entered final judgments as to The Movie Studio, Inc., a Florida-based movie company, and its President and CEO, Gordon Scott Venters, in connection with charges that they made material misrepresentations to investors in an unregistered securities offeringconducted over a multi-year period.
According to the SEC's complaint, The Movie Studio and Venters solicited investments from April 2017 through December 2020 using press releases and marketing materials that allegedly contained material misrepresentations and omissions concerning: (i) the company's ownership of various films; (ii) its film-production operations; (iii) its purported use of blockchain technology; and (iv) its alleged receipt of revenue from Amazon. The complaint alleged that they raised at least $1.2 million from more than 70 investors, many of whom were unsophisticated and elderly. The complaint further alleged that Venters used some investor funds for purposes unrelated to any legitimate business activity.
The Movie Studio and Venters consented to the entry of the final judgments, which permanently enjoin each from violating Sections 5(a) and 5(c) of the Securities Act of 1933. In addition, the final judgment as to Venters permanently enjoins him from violating Sections 17(a)(2) and 17(a)(3) of the Securities Act, and orders him to pay $69,000 in disgorgement, $17,735 in prejudgment interest, and a $100,000 civil penalty.
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Resources
* SEC Complaint (https://www.sec.gov/files/litigation/complaints/2026/comp26683.pdf)
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Original text here: https://www.sec.gov/enforcement-litigation/litigation-releases/lr-26683
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Securities and Exchange Commission v. The Movie Studio, Inc. et al., Civil Action No. 0:21-cv-61686-DPG (S.D. Fla. filed Aug. 13, 2021)
On October 15, 2026, the United States District Court for the Southern District of Florida entered final judgments as to The Movie Studio, Inc., a Florida-based movie company, and its President and CEO, Gordon Scott Venters, in connection with charges that they made material misrepresentations to investors in an unregistered securities offering ... Show Full Article WASHINGTON, Nov. 4 (TNSdock) -- The Securities and Exchange Commission issued the following litigation release: * * * Securities and Exchange Commission v. The Movie Studio, Inc. et al., Civil Action No. 0:21-cv-61686-DPG (S.D. Fla. filed Aug. 13, 2021) On October 15, 2026, the United States District Court for the Southern District of Florida entered final judgments as to The Movie Studio, Inc., a Florida-based movie company, and its President and CEO, Gordon Scott Venters, in connection with charges that they made material misrepresentations to investors in an unregistered securities offeringconducted over a multi-year period.
According to the SEC's complaint, The Movie Studio and Venters solicited investments from April 2017 through December 2020 using press releases and marketing materials that allegedly contained material misrepresentations and omissions concerning: (i) the company's ownership of various films; (ii) its film-production operations; (iii) its purported use of blockchain technology; and (iv) its alleged receipt of revenue from Amazon. The complaint alleged that they raised at least $1.2 million from more than 70 investors, many of whom were unsophisticated and elderly. The complaint further alleged that Venters used some investor funds for purposes unrelated to any legitimate business activity.
The Movie Studio and Venters consented to the entry of the final judgments, which permanently enjoin each from violating Sections 5(a) and 5(c) of the Securities Act of 1933. In addition, the final judgment as to Venters permanently enjoins him from violating Sections 17(a)(2) and 17(a)(3) of the Securities Act, and orders him to pay $69,000 in disgorgement, $17,735 in prejudgment interest, and a $100,000 civil penalty.
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Resources
* SEC Complaint (https://www.sec.gov/files/litigation/complaints/2026/comp26683.pdf)
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Original text here: https://www.sec.gov/enforcement-litigation/litigation-releases/lr-26683
Latin America and the Caribbean's Exports Rose 19.5%, Opening Opportunities to Attract More Foreign Investment, IDB Says
WASHINGTON, Nov. 4 -- The Inter-American Development Bank issued the following news release:
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Latin America and the Caribbean's Exports Rose 19.5%, Opening Opportunities to Attract More Foreign Investment, IDB Says
November 03, 2026
The region's year-on-year growth in the first half of 2026 outpaced the increase in global trade.
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WASHINGTON -- Goods exports from Latin America and the Caribbean grew 19.5% year-on-year in the first half of 2026, outpacing the 14.5% increase in world trade, driven by higher prices for oil and other commodities and by demand for infrastructure associated ... Show Full Article WASHINGTON, Nov. 4 -- The Inter-American Development Bank issued the following news release: * * * Latin America and the Caribbean's Exports Rose 19.5%, Opening Opportunities to Attract More Foreign Investment, IDB Says November 03, 2026 The region's year-on-year growth in the first half of 2026 outpaced the increase in global trade. - WASHINGTON -- Goods exports from Latin America and the Caribbean grew 19.5% year-on-year in the first half of 2026, outpacing the 14.5% increase in world trade, driven by higher prices for oil and other commodities and by demand for infrastructure associatedwith artificial intelligence (AI). The region's strong export performance opens an opportunity to attract more foreign investment, according to the Trade and Integration Monitor 2026 published by the Inter-American Development Bank (IDB).
The report notes that, despite a challenging global environment, the region delivered a strong performance, driven mainly by higher export volumes, with rising prices also contributing. Mexico led regional growth (24.6%) on the back of sales of AI infrastructure equipment to the United States. Export growth in the Caribbean (19.1%), concentrated in Guyana and Suriname, and in South America (16.5%) was driven by higher prices for mining and energy products, particularly oil.
"The trade resilience of Latin America and the Caribbean is an opportunity to attract more investment. To seize it, the region can pair its international trade and investment commitments with complementary domestic regulatory frameworks that give investors certainty," said Paolo Giordano, Principal Economist in the IDB's Productivity, Trade, and Innovation Sector.
Key findings of the Monitor
Greater presence in international markets: Latin America and the Caribbean's share of U.S. imports, the main destination for the region's export growth, reached a record high of 22.1% in the first half of 2026, even as U.S. purchases from the rest of the world declined. The region also regained market share in Europe.
Investment opportunities: Although the region still attracts more foreign direct investment (FDI) relative to the size of its economy than any other region, it received 4.5% less investment in 2023-2025 than in 2012-2014, and its share of the global FDI stock fell from 7.1% to 6.0%.
Regulatory architecture as a strategic asset: The region can benefit from double taxation treaties, bilateral investment treaties, and trade agreements with investment chapters, as these are associated with a higher likelihood of investment ties between countries.
According to the Monitor, the provisional application of the EU-Mercosur trade agreement, the modernization of other trade agreements, and the reshaping of global value chains driven by artificial intelligence and the energy transition open a window of opportunity for the region. The report therefore argues that the region's external trade agenda should be accompanied by complementary reforms to national regulatory frameworks and by investment in public goods that lower the costs faced by private companies when expanding into international markets.
About the IDB
The Inter-American Development Bank (IDB), a member of IDB Group, is devoted to improving lives across Latin America and the Caribbean. Founded in 1959, the IDB works with the region's public sector to design and enable impactful, innovative solutions for sustainable and inclusive development. Leveraging financing, technical expertise, and knowledge, the IDB promotes growth and well-being in 26 countries. Visit our website: www.iadb.org/en
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Original text here: https://www.iadb.org/en/news/latin-america-and-caribbeans-exports-rose-195-opening-opportunities-attract-more-foreign-investment
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Latin America and the Caribbean's Exports Rose 19.5%, Opening Opportunities to Attract More Foreign Investment, IDB Says
November 03, 2026
The region's year-on-year growth in the first half of 2026 outpaced the increase in global trade.
-
WASHINGTON -- Goods exports from Latin America and the Caribbean grew 19.5% year-on-year in the first half of 2026, outpacing the 14.5% increase in world trade, driven by higher prices for oil and other commodities and by demand for infrastructure associated ... Show Full Article WASHINGTON, Nov. 4 -- The Inter-American Development Bank issued the following news release: * * * Latin America and the Caribbean's Exports Rose 19.5%, Opening Opportunities to Attract More Foreign Investment, IDB Says November 03, 2026 The region's year-on-year growth in the first half of 2026 outpaced the increase in global trade. - WASHINGTON -- Goods exports from Latin America and the Caribbean grew 19.5% year-on-year in the first half of 2026, outpacing the 14.5% increase in world trade, driven by higher prices for oil and other commodities and by demand for infrastructure associatedwith artificial intelligence (AI). The region's strong export performance opens an opportunity to attract more foreign investment, according to the Trade and Integration Monitor 2026 published by the Inter-American Development Bank (IDB).
The report notes that, despite a challenging global environment, the region delivered a strong performance, driven mainly by higher export volumes, with rising prices also contributing. Mexico led regional growth (24.6%) on the back of sales of AI infrastructure equipment to the United States. Export growth in the Caribbean (19.1%), concentrated in Guyana and Suriname, and in South America (16.5%) was driven by higher prices for mining and energy products, particularly oil.
"The trade resilience of Latin America and the Caribbean is an opportunity to attract more investment. To seize it, the region can pair its international trade and investment commitments with complementary domestic regulatory frameworks that give investors certainty," said Paolo Giordano, Principal Economist in the IDB's Productivity, Trade, and Innovation Sector.
Key findings of the Monitor
Greater presence in international markets: Latin America and the Caribbean's share of U.S. imports, the main destination for the region's export growth, reached a record high of 22.1% in the first half of 2026, even as U.S. purchases from the rest of the world declined. The region also regained market share in Europe.
Investment opportunities: Although the region still attracts more foreign direct investment (FDI) relative to the size of its economy than any other region, it received 4.5% less investment in 2023-2025 than in 2012-2014, and its share of the global FDI stock fell from 7.1% to 6.0%.
Regulatory architecture as a strategic asset: The region can benefit from double taxation treaties, bilateral investment treaties, and trade agreements with investment chapters, as these are associated with a higher likelihood of investment ties between countries.
According to the Monitor, the provisional application of the EU-Mercosur trade agreement, the modernization of other trade agreements, and the reshaping of global value chains driven by artificial intelligence and the energy transition open a window of opportunity for the region. The report therefore argues that the region's external trade agenda should be accompanied by complementary reforms to national regulatory frameworks and by investment in public goods that lower the costs faced by private companies when expanding into international markets.
About the IDB
The Inter-American Development Bank (IDB), a member of IDB Group, is devoted to improving lives across Latin America and the Caribbean. Founded in 1959, the IDB works with the region's public sector to design and enable impactful, innovative solutions for sustainable and inclusive development. Leveraging financing, technical expertise, and knowledge, the IDB promotes growth and well-being in 26 countries. Visit our website: www.iadb.org/en
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Original text here: https://www.iadb.org/en/news/latin-america-and-caribbeans-exports-rose-195-opening-opportunities-attract-more-foreign-investment
Justice Dept.: Ohio Pet Breeder Agrees to Surrender Over 1,100 Chinchillas
WASHINGTON, Nov. 4 -- The U.S. Department of Justice issued the following news release:
Ohio Pet Breeder Agrees to Surrender Over 1,100 Chinchillas
November 3, 2026
Justice Department Secured Veterinary Access for the Animals Over Last Three Months
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The U.S. District Court for the Northern District of Ohio yesterday endorsed a consent decree entered between the United States and the owner of R & R Chinchilla Inc. to surrender over 300 remaining chinchillas at a breeding facility in Jenera, Ohio. The court order follows R & R Chinchilla's voluntary surrender of roughly 800 additional chinchillas ... Show Full Article WASHINGTON, Nov. 4 -- The U.S. Department of Justice issued the following news release: Ohio Pet Breeder Agrees to Surrender Over 1,100 Chinchillas November 3, 2026 Justice Department Secured Veterinary Access for the Animals Over Last Three Months - The U.S. District Court for the Northern District of Ohio yesterday endorsed a consent decree entered between the United States and the owner of R & R Chinchilla Inc. to surrender over 300 remaining chinchillas at a breeding facility in Jenera, Ohio. The court order follows R & R Chinchilla's voluntary surrender of roughly 800 additional chinchillasto animal welfare organizations pursuant to a modified temporary restraining order.
"Animal breeders and caretakers that are federally licensed have an obligation to comply with basic standards Congress established to provide clean water, adequate food and housing, and sufficient veterinary care to their animals," said Principal Deputy Assistant Attorney General Adam Gustafson of the Justice Department's Energy and Natural Resources Division (ENRD). "We appreciate that the settlement agreement we reached in this matter has led to the safe relocation of all the animals involved. The heart of the Animal Welfare Act is to make sure animals are receiving good care, and that is what happened here. We highlight this case to show that we will enforce the law and hold violators accountable."
"Federally licensed pet breeders must adhere to the Animal Welfare Act. Animals cannot be abused, kept in dirty cages, and neglected so badly that they suffer or die. We will hold those violating these federal laws accountable," said U.S. Attorney David M. Toepfer for the Northern District of Ohio. "We are thankful for the great work of the USDA investigators which has resulted in the surrender of the animals that were in the breeding facility involved in this matter."
"Over multiple inspections, APHIS inspectors documented deeply troubling conditions at this facility, including animals with untreated medical conditions, excessive fecal accumulation, and the concealment of approximately 800 additional chinchillas in a second structure that had been withheld from inspection for years," said Deputy Administrator Bernadette Juarez of USDA's Animal and Plant Health Inspection Service (APHIS)'s Animal Care program. "USDA has a responsibility to ensure that licensed facilities meet the standards required under the Animal Welfare Act, and the conditions identified at this facility reflected a prolonged failure to provide basic animal care. After issuing an official warning in 2024 and taking multiple enforcement actions, including two summary suspensions, USDA worked closely with the Department of Justice to advance this case. We are grateful for the court's action, which enabled the safe removal of approximately 800 chinchillas from the facility and gives these animals the opportunity to receive the care they urgently need. We also welcome the revocation of the facility's Animal Welfare Act license, which reflects the seriousness of the violations documented by our inspectors. APHIS will continue to take strong enforcement action when serious or repeated noncompliance threatens animal welfare and undermines public trust in licensed operations."
After receiving a referral from the U.S. Department of Agriculture (USDA) that animals were in serious danger, the Justice Department in August filed a complaint against R & R Chinchilla and its president, James. F. Ritterspach. The complaint alleged failures on multiple occasions to comply with the Animal Welfare Act (AWA) and its regulations and standards for the humane care, handling, and treatment of around 1,100 chinchillas at the R & R Chinchilla's Hancock County facility. R & R Chinchilla has bred chinchillas for over 40 years. Chinchillas are small animals with dense, soft fur, weighing one to two pounds, and are typically categorized as exotic pets.
According to the complaint, since September 2022 the USDA conducted 18 inspections of R & R Chinchilla's facility. In nearly every inspection, multiple violations of the AWA were identified, with 59 violations occurring within the past four years. For example, inspectors observed Ritterspach ripping a four-by-six-inch mat of hair off a chinchilla while holding the animal by the tail. The complaint alleged that R & R Chinchilla, through Ritterspach, falsely represented to USDA inspectors that it had between 300 to 450 animals at its facility. In reality, Ritterspach for years allegedly concealed about 800 additional animals in a separate building to avoid inspection of those animals.
On Aug. 5, USDA inspectors gained access to evaluate this previously undisclosed building and found hundreds of animals in dire conditions. The inspectors noted that the building was in worse condition than any facility they had ever inspected. Inspectors also observed multiple dead animals in the facility. Alleged AWA violations include:
* Animals found with eyes so swollen and oozing with discharge that they could not open them;
* Fecal material covering the entire floor of hundreds of enclosures;
* Ammonia levels that were so high it caused USDA inspectors to cough to the point of having to leave the building;
* Open packets of rat poison kept right next to enclosures housing chinchillas; and
* A metal collar becoming tightly embedded in the neck of an animal.
ENRD and the U.S. Attorney's Office for the Northern District of Ohio filed a temporary restraining order and preliminary injunction motion on Aug. 20. The court granted the temporary restraining order on Aug. 21 and later issued a modified order agreed to by the parties, adding to the measures already in place to address some of the alleged chronic issues at the facility. Furthermore, the order required R & R Chinchilla and Ritterspach to work with the United States to surrender approximately 800 of the animals at their facility. Under the terms of the consent decree, Ritterspach agreed to relinquish the remaining chinchillas and permanently cease any further AWA-regulated activity. Ritterspach also entered into a consent decree and order with USDA that permanently revokes Ritterspach's AWA license.
Attorneys Kamela A. Caschette, Bonnie M. Ballard, and Davis A. Backer of ENRD's Wildlife and Marine Resources Section, and Assistant U.S. Attorney Bill Rojas for the Northern District of Ohio are handling this matter.
To report animal welfare violations, you can file a complaint on the USDA's website.
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Original text here: https://www.justice.gov/opa/pr/ohio-pet-breeder-agrees-surrender-over-1100-chinchillas
Ohio Pet Breeder Agrees to Surrender Over 1,100 Chinchillas
November 3, 2026
Justice Department Secured Veterinary Access for the Animals Over Last Three Months
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The U.S. District Court for the Northern District of Ohio yesterday endorsed a consent decree entered between the United States and the owner of R & R Chinchilla Inc. to surrender over 300 remaining chinchillas at a breeding facility in Jenera, Ohio. The court order follows R & R Chinchilla's voluntary surrender of roughly 800 additional chinchillas ... Show Full Article WASHINGTON, Nov. 4 -- The U.S. Department of Justice issued the following news release: Ohio Pet Breeder Agrees to Surrender Over 1,100 Chinchillas November 3, 2026 Justice Department Secured Veterinary Access for the Animals Over Last Three Months - The U.S. District Court for the Northern District of Ohio yesterday endorsed a consent decree entered between the United States and the owner of R & R Chinchilla Inc. to surrender over 300 remaining chinchillas at a breeding facility in Jenera, Ohio. The court order follows R & R Chinchilla's voluntary surrender of roughly 800 additional chinchillasto animal welfare organizations pursuant to a modified temporary restraining order.
"Animal breeders and caretakers that are federally licensed have an obligation to comply with basic standards Congress established to provide clean water, adequate food and housing, and sufficient veterinary care to their animals," said Principal Deputy Assistant Attorney General Adam Gustafson of the Justice Department's Energy and Natural Resources Division (ENRD). "We appreciate that the settlement agreement we reached in this matter has led to the safe relocation of all the animals involved. The heart of the Animal Welfare Act is to make sure animals are receiving good care, and that is what happened here. We highlight this case to show that we will enforce the law and hold violators accountable."
"Federally licensed pet breeders must adhere to the Animal Welfare Act. Animals cannot be abused, kept in dirty cages, and neglected so badly that they suffer or die. We will hold those violating these federal laws accountable," said U.S. Attorney David M. Toepfer for the Northern District of Ohio. "We are thankful for the great work of the USDA investigators which has resulted in the surrender of the animals that were in the breeding facility involved in this matter."
"Over multiple inspections, APHIS inspectors documented deeply troubling conditions at this facility, including animals with untreated medical conditions, excessive fecal accumulation, and the concealment of approximately 800 additional chinchillas in a second structure that had been withheld from inspection for years," said Deputy Administrator Bernadette Juarez of USDA's Animal and Plant Health Inspection Service (APHIS)'s Animal Care program. "USDA has a responsibility to ensure that licensed facilities meet the standards required under the Animal Welfare Act, and the conditions identified at this facility reflected a prolonged failure to provide basic animal care. After issuing an official warning in 2024 and taking multiple enforcement actions, including two summary suspensions, USDA worked closely with the Department of Justice to advance this case. We are grateful for the court's action, which enabled the safe removal of approximately 800 chinchillas from the facility and gives these animals the opportunity to receive the care they urgently need. We also welcome the revocation of the facility's Animal Welfare Act license, which reflects the seriousness of the violations documented by our inspectors. APHIS will continue to take strong enforcement action when serious or repeated noncompliance threatens animal welfare and undermines public trust in licensed operations."
After receiving a referral from the U.S. Department of Agriculture (USDA) that animals were in serious danger, the Justice Department in August filed a complaint against R & R Chinchilla and its president, James. F. Ritterspach. The complaint alleged failures on multiple occasions to comply with the Animal Welfare Act (AWA) and its regulations and standards for the humane care, handling, and treatment of around 1,100 chinchillas at the R & R Chinchilla's Hancock County facility. R & R Chinchilla has bred chinchillas for over 40 years. Chinchillas are small animals with dense, soft fur, weighing one to two pounds, and are typically categorized as exotic pets.
According to the complaint, since September 2022 the USDA conducted 18 inspections of R & R Chinchilla's facility. In nearly every inspection, multiple violations of the AWA were identified, with 59 violations occurring within the past four years. For example, inspectors observed Ritterspach ripping a four-by-six-inch mat of hair off a chinchilla while holding the animal by the tail. The complaint alleged that R & R Chinchilla, through Ritterspach, falsely represented to USDA inspectors that it had between 300 to 450 animals at its facility. In reality, Ritterspach for years allegedly concealed about 800 additional animals in a separate building to avoid inspection of those animals.
On Aug. 5, USDA inspectors gained access to evaluate this previously undisclosed building and found hundreds of animals in dire conditions. The inspectors noted that the building was in worse condition than any facility they had ever inspected. Inspectors also observed multiple dead animals in the facility. Alleged AWA violations include:
* Animals found with eyes so swollen and oozing with discharge that they could not open them;
* Fecal material covering the entire floor of hundreds of enclosures;
* Ammonia levels that were so high it caused USDA inspectors to cough to the point of having to leave the building;
* Open packets of rat poison kept right next to enclosures housing chinchillas; and
* A metal collar becoming tightly embedded in the neck of an animal.
ENRD and the U.S. Attorney's Office for the Northern District of Ohio filed a temporary restraining order and preliminary injunction motion on Aug. 20. The court granted the temporary restraining order on Aug. 21 and later issued a modified order agreed to by the parties, adding to the measures already in place to address some of the alleged chronic issues at the facility. Furthermore, the order required R & R Chinchilla and Ritterspach to work with the United States to surrender approximately 800 of the animals at their facility. Under the terms of the consent decree, Ritterspach agreed to relinquish the remaining chinchillas and permanently cease any further AWA-regulated activity. Ritterspach also entered into a consent decree and order with USDA that permanently revokes Ritterspach's AWA license.
Attorneys Kamela A. Caschette, Bonnie M. Ballard, and Davis A. Backer of ENRD's Wildlife and Marine Resources Section, and Assistant U.S. Attorney Bill Rojas for the Northern District of Ohio are handling this matter.
To report animal welfare violations, you can file a complaint on the USDA's website.
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Original text here: https://www.justice.gov/opa/pr/ohio-pet-breeder-agrees-surrender-over-1100-chinchillas
First HH-60W Arrives at America's Airfield, Marking New Era for Air Force Rotary-wing Operations
JOINT BASE ANDREWS, Maryland, Nov. 4 -- The U.S. Air Force Joint Base Andrews (316th Wing) issued the following news:
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Nov. 2, 2026
First HH-60W arrives at America's Airfield, marking new era for Air Force rotary-wing operations
By Senior Airman Alexis Redin 316th Wing Public Affairs
JOINT BASE ANDREWS, Md. - Joint Base Andrews marked a historic milestone Nov. 2, 2026, with the arrival of the first HH-60W Jolly Green II, bringing a new generation of Air Force rotary-wing capabilities to the nation's capital for the first time in 60 years.
The Air Force has flown the UH-1N "Huey" out ... Show Full Article JOINT BASE ANDREWS, Maryland, Nov. 4 -- The U.S. Air Force Joint Base Andrews (316th Wing) issued the following news: * * * Nov. 2, 2026 First HH-60W arrives at America's Airfield, marking new era for Air Force rotary-wing operations By Senior Airman Alexis Redin 316th Wing Public Affairs JOINT BASE ANDREWS, Md. - Joint Base Andrews marked a historic milestone Nov. 2, 2026, with the arrival of the first HH-60W Jolly Green II, bringing a new generation of Air Force rotary-wing capabilities to the nation's capital for the first time in 60 years. The Air Force has flown the UH-1N "Huey" outof Andrews for decades, but with the arrival of the HH-60W, the service will now bring significantly expanded capabilities to the National Capitol Region.
"Our leaders recognized the need for change and decided to rapidly modernize the equipment that we use to protect our nation," said U.S. Air Force Col. Karl W. Seekamp, 316th Wing and installation commander. "...this critical mission deserves the modern capability and safety upgrades that are available today."
With a larger airframe and bigger fuel capacity, the Jolly Green II can fly faster and farther, extending the operational reach of the Air Force's response in times of crisis and contingency. It also provides nearly three times the airlift capability of the UH-1N.
The arrival of the Jolly Green II represents a new chapter in the Air Force's rotary-wing history, building on a legacy established by the 1st Helicopter Squadron, which served as the Air Force's only rotary-wing unit in the National Capital Region for six decades.
The aircraft will first be assigned to the 5th Helicopter Squadron, which is charged with training the force and establishing the new fleet, while the 1st HS will fly the UH-1N to provide continuous support of Andrews' 24/7 no-fail national security mission.
Since 1969, the 1st HS has conducted immediate-response contingency operations in support of critical national security requirements while maintaining a rigorous training schedule to ensure mission readiness. The squadron has flown the UH-1N Huey since 1971, and three of the aircraft that flew during the Vietnam War remain in service today.
That history is an important part of the transition to the Jolly Green II.
"It is important that we honor the legacy of what the Huey has done for safety and operations as a whole," noted U.S. Air Force Lt. Col. Jonathan Bonilla, 5th HS commander. "We must remember this while we, as an Air Force, continue to look into the future."
While the Huey has a storied history of saving lives through its light-lift capabilities, particularly during the Vietnam War, the arrival of the HH-60W represents an investment in modernizing the Andrews' rotary-wing capabilities and providing a more versatile aircraft to meet evolving operational requirements.
"I think the [HH-60] Whiskey is absolutely the right call," said U.S. Air Force Capt. Joshua Lemon, 316th Operations Group executive officer and UH-1N instructor pilot, who will be part of the first class of aircrew transitioning to the new aircraft. "It is inherently a joint airframe, meaning that almost any branch or agency in the area can call on us and we can lend a hand, or an aircraft. It makes us part of a bigger team."
Although rotary-wing aircraft represent a small but vital part of the Air Force, their maneuverability and ability to operate in areas inaccessible to many fixed-wing aircraft make them essential to a wide range of missions. The arrival of the Jolly Green II ensures Andrews' long-term ability to respond to national security requirements across the nation's capital.
Introducing a new airframe also strengthens the Wing's readiness for future mission needs and modernizes a crucial fleet of aircraft that supports U.S. senior leaders. Beginning in 2027, designated classes of Airmen from Andrews' helicopter squadrons will receive familiarization training from certified Sikorsky aircrews. Following the course, select Airmen will be qualified to instruct their fellow crewmembers in HH-60W safety and familiarization procedures. As each class graduates, both the 1st and 5th HS will have a growing team of aircrew who can fly both the HH-60W and the UH-1N, enabling 24/7 continuous support.
As the Jolly Green II takes its place on the Andrews flightline, it carries forward a mission shaped by decades of service. The Huey's legacy remains an enduring part of that history, while the arrival of the HH-60W ensures the installation is equipped to meet the demands of the future.
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Original text here: https://www.jba.af.mil/News/Article/4639897/first-hh-60w-arrives-at-americas-airfield-marking-new-era-for-air-force-rotary/
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Nov. 2, 2026
First HH-60W arrives at America's Airfield, marking new era for Air Force rotary-wing operations
By Senior Airman Alexis Redin 316th Wing Public Affairs
JOINT BASE ANDREWS, Md. - Joint Base Andrews marked a historic milestone Nov. 2, 2026, with the arrival of the first HH-60W Jolly Green II, bringing a new generation of Air Force rotary-wing capabilities to the nation's capital for the first time in 60 years.
The Air Force has flown the UH-1N "Huey" out ... Show Full Article JOINT BASE ANDREWS, Maryland, Nov. 4 -- The U.S. Air Force Joint Base Andrews (316th Wing) issued the following news: * * * Nov. 2, 2026 First HH-60W arrives at America's Airfield, marking new era for Air Force rotary-wing operations By Senior Airman Alexis Redin 316th Wing Public Affairs JOINT BASE ANDREWS, Md. - Joint Base Andrews marked a historic milestone Nov. 2, 2026, with the arrival of the first HH-60W Jolly Green II, bringing a new generation of Air Force rotary-wing capabilities to the nation's capital for the first time in 60 years. The Air Force has flown the UH-1N "Huey" outof Andrews for decades, but with the arrival of the HH-60W, the service will now bring significantly expanded capabilities to the National Capitol Region.
"Our leaders recognized the need for change and decided to rapidly modernize the equipment that we use to protect our nation," said U.S. Air Force Col. Karl W. Seekamp, 316th Wing and installation commander. "...this critical mission deserves the modern capability and safety upgrades that are available today."
With a larger airframe and bigger fuel capacity, the Jolly Green II can fly faster and farther, extending the operational reach of the Air Force's response in times of crisis and contingency. It also provides nearly three times the airlift capability of the UH-1N.
The arrival of the Jolly Green II represents a new chapter in the Air Force's rotary-wing history, building on a legacy established by the 1st Helicopter Squadron, which served as the Air Force's only rotary-wing unit in the National Capital Region for six decades.
The aircraft will first be assigned to the 5th Helicopter Squadron, which is charged with training the force and establishing the new fleet, while the 1st HS will fly the UH-1N to provide continuous support of Andrews' 24/7 no-fail national security mission.
Since 1969, the 1st HS has conducted immediate-response contingency operations in support of critical national security requirements while maintaining a rigorous training schedule to ensure mission readiness. The squadron has flown the UH-1N Huey since 1971, and three of the aircraft that flew during the Vietnam War remain in service today.
That history is an important part of the transition to the Jolly Green II.
"It is important that we honor the legacy of what the Huey has done for safety and operations as a whole," noted U.S. Air Force Lt. Col. Jonathan Bonilla, 5th HS commander. "We must remember this while we, as an Air Force, continue to look into the future."
While the Huey has a storied history of saving lives through its light-lift capabilities, particularly during the Vietnam War, the arrival of the HH-60W represents an investment in modernizing the Andrews' rotary-wing capabilities and providing a more versatile aircraft to meet evolving operational requirements.
"I think the [HH-60] Whiskey is absolutely the right call," said U.S. Air Force Capt. Joshua Lemon, 316th Operations Group executive officer and UH-1N instructor pilot, who will be part of the first class of aircrew transitioning to the new aircraft. "It is inherently a joint airframe, meaning that almost any branch or agency in the area can call on us and we can lend a hand, or an aircraft. It makes us part of a bigger team."
Although rotary-wing aircraft represent a small but vital part of the Air Force, their maneuverability and ability to operate in areas inaccessible to many fixed-wing aircraft make them essential to a wide range of missions. The arrival of the Jolly Green II ensures Andrews' long-term ability to respond to national security requirements across the nation's capital.
Introducing a new airframe also strengthens the Wing's readiness for future mission needs and modernizes a crucial fleet of aircraft that supports U.S. senior leaders. Beginning in 2027, designated classes of Airmen from Andrews' helicopter squadrons will receive familiarization training from certified Sikorsky aircrews. Following the course, select Airmen will be qualified to instruct their fellow crewmembers in HH-60W safety and familiarization procedures. As each class graduates, both the 1st and 5th HS will have a growing team of aircrew who can fly both the HH-60W and the UH-1N, enabling 24/7 continuous support.
As the Jolly Green II takes its place on the Andrews flightline, it carries forward a mission shaped by decades of service. The Huey's legacy remains an enduring part of that history, while the arrival of the HH-60W ensures the installation is equipped to meet the demands of the future.
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Original text here: https://www.jba.af.mil/News/Article/4639897/first-hh-60w-arrives-at-americas-airfield-marking-new-era-for-air-force-rotary/
FDA Center for Drug Evaluation & Research Issues Warning Letter to Pritam International
WASHINGTON, Nov. 4 (TNSdock) -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Pritam International Private Limited from its Center for Drug Evaluation and Research:
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Recipient: Dr. Rahul Mahajan Sr, General Manager Quality, Pritam International Private Limited, Khasra No. 138, Raipur Industrial Area Bhagwanpur, Haridwar 247667 Uttarakhand, India, rahul.mahajan@wonderproducts.co.in
Issuing Office: Center for Drug Evaluation and Research (CDER), United States
WARNING LETTER
Reference number: 320-27-12
To Dr. Rahul Mahajan:
This ... Show Full Article WASHINGTON, Nov. 4 (TNSdock) -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Pritam International Private Limited from its Center for Drug Evaluation and Research: * * * Recipient: Dr. Rahul Mahajan Sr, General Manager Quality, Pritam International Private Limited, Khasra No. 138, Raipur Industrial Area Bhagwanpur, Haridwar 247667 Uttarakhand, India, rahul.mahajan@wonderproducts.co.in Issuing Office: Center for Drug Evaluation and Research (CDER), United States WARNING LETTER Reference number: 320-27-12 To Dr. Rahul Mahajan: Thiswarning letter advises you of significant violations identified during a U.S. Food and Drug Administration (FDA) inspection of your facility and during a review of records submitted from your facility and provides you an opportunity to address them. Promptly address any violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that exist at your facility. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address any violations may result in regulatory action without further notice.
FDA Review
Violations were identified and documented during review of your drug manufacturing facility, Pritam International Private Limited, FDA Establishment Identifier (FEI) 3020826443. This review was conducted under FDA's statutory authority and public health responsibilities to protect the public from unsafe, ineffective, and poor quality drugs.
Your facility is registered with the FDA as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our April 24, 2026, request for records and other information pursuant to section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for your facility.
FDA Inspection
Violations were also identified and documented during an inspection of your drug manufacturing facility, Pritam International Private Limited, FEI 3020826443 from June 2 to 6, 2026. This inspection was conducted under FDA's statutory authority and public health responsibilities to protect the public from unsafe, ineffective, and poor quality drugs.
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 FD&C Act, 21 U.S.C. 351(a)(2)(B).
In addition, your "Brush Buddies Cookies 'n Cream Ice Cream Flavored Toothpaste" is adulterated under section 501(a)(4)(A) as this drug product bears or contains a color additive that is unsafe within the meaning of section 721 of the FD&C Act, 21 U.S.C. 379e. Accordingly, the introduction or delivery for introduction of "Brush Buddies Cookies 'n Cream Ice Cream Flavored Toothpaste" into interstate commerce is a prohibited act under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
We reviewed your May 11, 2026, response to our request for records in detail, and your June 25, 2026, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.
Violations of the Federal Food, Drug, and Cosmetic Act
The following are violations identified during our inspection and our records review. As a reminder, this is not an all-inclusive list of violations at your facility.
Adulterated within the meaning of section 501(a)(4)(A) of the FD&C Act
Your firm contract manufactures OTC toothpaste and (b)(4) drug products for distribution to the U.S. market. Your toothpaste drug products are indicated for use in both children and adults.
Based on our review of batch records and product labels, your "Brush Buddies Cookies 'n Cream Ice Cream Flavored Toothpaste" contains the color additive "CI 14720" (also known as Ext. D&C Red No. 10 or Acid Red No. 14 or Food Red 3 or Carmoisine or Azorubine (E122)). In 1966, FDA cancelled the certification and delisted Ext. D&C Red No. 10 due to lack of safety data from any manufacturer. Under 21 CFR 81.30(d), using Ext. D&C Red No.10 after October 4, 1966, results in the drug being adulterated.
Any color additive not explicitly listed as safe for its intended use is deemed unsafe within the meaning of section 721(a) of the FD&C Act. The inclusion of a delisted color additive in your drug product formulation indicates that your quality unit's review (as required under 21 CFR 211.22) of your raw material qualification process and formulation review procedures are inadequate to ensure that only acceptable ingredients are used in the manufacture of drug products, especially those marketed to children.
In response to this letter, provide:
* A risk assessment to review all your drug formulations to ensure the use of appropriate color additives, including any that may use alternate names. For more information, see the webpage for Regulatory Status of Color Additives at https://www.hfpappexternal.fda.gov/scripts/fdcc/index.cfm?set=ColorAdditives.
Adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act
1. 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)).
You lacked complete and original laboratory data demonstrating that the required testing was performed.
You use (b)(4) as a major component of your drug products. During the inspection, we observed multiple media plates with (b)(4) for (b)(4) samples in your incubator with visible microbiological growth. However, on the next day, during plate reading and result recording, there was no visible microbiological growth on plates labeled as the same samples observed the day before. Additionally, we identified multiple discrepancies between the labeling of the sample identification information handwritten on the exterior of the plates from one day to the subsequent day.
Microbiological monitoring and testing are essential quality control steps that are integral to ensure raw materials are adequate for use. Such programs provide critical information on the state of control of the manufacturing operation. Substitution of unreliable or false results fundamentally compromises a facility's ability to identify risks to the drug product.
In your response, you indicate that an investigation into the falsified results concluded that the "... transposition of plates ..." was a deliberate but isolated act by the microbiologist to circumvent your procedure. You state that you retrained the microbiologists to recognize when a plate should be considered Too Numerous To Count (TNTC), introduced a tamper evident seal for the plate, implemented color coding to differentiate the negative control plate from the product or component sample, and mandated that all microbiological plate reading must be performed by two analysts concurrently prior to data entry.
Your response is inadequate since you fail to address the severity of the observed data integrity violation for the falsification and alteration of the microbiological test results. Your proposed corrective actions address the data integrity breaches as isolated procedural gaps rather than as evidence of a systemic breakdown in quality unit (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.
Microbiological testing, an essential quality control step, is integral in preventing distribution of unsafe products. Integrity of data is fundamentally compromised when there is a failure to record or maintain complete and accurate records of test results or conditions associated with drug testing. Furthermore, the lack of reliable data compromises the QU's ability to exercise its function of ensuring compliance with applicable standards.
In response to this letter, provide:
* A comprehensive, independent assessment of your laboratory practices, procedures, methods, equipment, documentation, supervisory oversight, and analyst competencies. Based on this review, provide a detailed plan to remediate and evaluate the effectiveness of your laboratory system.
* A comprehensive, independent assessment 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 (ALCOA) records throughout your operation.
* A comprehensive CAPA, overseen by a qualified consultant, for handling microbiological sampling media to ensure robust and reliable data. Establish a system that ensures uninterrupted and uncompromised custody, with full reconciliation of all microbiological samples, including but not limited to:
o unique labeling of each sample
o signatures of all staff who handle the sample
o complete tracking of sample integrity and custody
o date and time of each activity (e.g., sample collection, transport, delivery, incubation, removal from incubator)
o digital time-stamped photos of all plates at the time of plate reading
o laboratory tools (e.g., magnification, appropriate light) and methods that optimize visibility and detectability of colonies on plates
o signatures of personnel performing reading of microbial counts
o provisions for verifications and routine quality assurance oversight
2. Your firm failed to conduct at least one test to verify the identity of each component of a drug product. Your firm also failed to validate and establish the reliability of your component supplier's test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)).
You failed to perform adequate identity testing for each component lot used in the production of your OTC drug products. You relied on the certificates of analysis (COAs) from your suppliers and failed to establish the reliability of each of your suppliers' COA for component specifications and characteristics.
Products Contain Ingredients at Risk for Diethylene Glycol or Ethylene Glycol (DEG or EG) Contamination
You manufacture multiple toothpaste drug products (intended for adults and children) that contain sorbitol solution. You failed to adequately test your incoming components at high risk of DEG and EG contamination for identity before using them to manufacture your drug products. For example, during the inspection, you provided our investigators with one COA with independent identity testing results, including DEG and EG, out of approximately (b)(4) shipments of sorbitol solution. Identity testing, including DEG and EG, is required for each lot that you receive.
The use of ingredients contaminated with DEG or EG has resulted in various lethal poisoning incidents in humans worldwide. See FDA's guidance document, Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol, to help you meet the CGMP requirements when manufacturing drugs containing ingredients at high-risk for DEG or EG contamination at https://www.fda.gov/media/167974/download.
In your response, you proposed modifying the receipt of drums and tanker trucks of the sorbitol solution component to perform identity testing prior to use in manufacturing. You also indicated that you would perform destructive testing of all finished drug product reserve (control) samples.
Your response is inadequate. You did not provide any additional evidence that sorbitol solution had been properly tested to confirm identity prior to use. Furthermore, you did not address whether identity testing is performed for other potential high-risk components (such as glycerin and polyethylene glycol).
Without appropriate testing of components and ingredients, you cannot ensure the quality and safety of your drug products. Without adequate testing and confirmation of reliability of supplier and external laboratory testing results, you lack scientific evidence that the components or drug products conform to appropriate specifications.
In response to this letter, provide:
* A commitment to provide DEG and EG test results, no later than 30 calendar days from the date of this letter, from testing retains for all lots of high-risk drug components used in the manufacture of drug products. Alternatively, if a retain of a component lot is unavailable, perform retain sample testing of all implicated finished drug product batches for the presence of DEG and EG.
* A full risk assessment for drug products that are within expiry which contain any ingredient at risk for DEG or EG contamination (including, but not limited to, glycerin). Take prompt and appropriate actions to determine the safety of all lots of the component(s) and any related drug product that could contain DEG or EG, including customer notifications and product recalls for any contaminated lots. Identify additional appropriate CAPA that secure supply chains in the future, including, but not limited to, ensuring that all incoming raw material lots are from fully qualified manufacturers and free from unsafe impurities. Detail these actions in your response to this letter.
* A description of how you will test each component lot for conformity with all appropriate specifications for identity, strength, quality, and purity. If you intend to accept any results from your supplier's COA instead of testing each component lot for strength, quality, and purity, specify how you will robustly establish the reliability of your supplier's results through initial validation as well as periodic revalidation. In addition, include a commitment to always conduct at least one specific identity test for each incoming component lot. In the case of glycerin, propylene glycol, and certain additional high-risk components we note that this includes the performance of parts A, B, and C of the United States Pharmacopeia (USP) monograph.
* The chemical quality control specifications you use to test each incoming lot of high-risk drug components to determine acceptability for use in manufacturing.
* A comprehensive, independent review of your material system to determine whether all suppliers of components, containers, and closures, are each qualified and the materials are assigned appropriate expiration or retest dates. The review should also determine whether incoming material controls are adequate to prevent use of unsuitable components, containers, and closures.
* A summary of results obtained from testing all components to evaluate the reliability of the COA from each component manufacturer. Include your SOP that describes this COA validation program.
3. Your firm's quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).
Your QU failed to exercise its authority and responsibilities over your drug manufacturing operations, including ensuring the data integrity of your records. For example, the QU failed to ensure:
* (b)(4) was suitable for its intended use (21 CFR 211.100).
* An adequate training program for your microbiology laboratory employees that objectively evaluated competency and proficiency results to assess training effectiveness (21 CFR 211.25(c)).
* Adequate laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures (21 CFR 211.160(b)).
For help implementing quality system and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211, see FDA's guidance documents Quality Systems Approach to Pharmaceutical CGMP Regulations at https://www.fda.gov/media/71023/download, as well as ICH Q10 Pharmaceutical Quality System at https://www.fda.gov/media/71553/download.
In response to this letter, provide:
* 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:
o A determination of whether procedures used by your firm are robust and appropriate
o Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices
o A complete and final review of each batch and its related information before the QU disposition decision
o Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products
o Also describe how top management supports quality assurance and reliable operations including, but not limited to, timely provision of resources to proactively address emerging quality issues and to assure a continuing state of control.
* A comprehensive remediation plan for the design, control, and maintenance of the water system, including:
o A comprehensive evaluation of vulnerabilities of water system design and control and summarize all deficiencies found in the system. The summary should, at minimum, describe various system characteristics that were assessed for adequacy (system temperature, materials of construction, slope, any identified dead-legs, any stagnant locations, any unsanitary fittings, flow velocity, etc.)
* Your total microbiological count limits to monitor whether this system produces water suitable for the intended uses for each of your products.
* A detailed risk assessment addressing the potential effects of the observed water system failures on the quality of all drug product lots currently in U.S. distribution. Specify actions that you will take in response to the risk assessment, such as customer notifications and product recalls.
CGMP Consultant Recommended
Based upon the nature of the violations we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 211.34 to evaluate your operations and to assist your firm in meeting CGMP requirements if your firm intends to resume manufacturing drugs for the U.S. market. The qualified consultant should also perform a comprehensive six-system audit of your entire operation for CGMP compliance and evaluate the completion and efficacy of your CAPA before you pursue resolution of your firm's compliance status with FDA.
Your use of a consultant does not relieve your firm's obligation to comply with CGMP. Your firm's executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.
Data Integrity Remediation
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, qualified third-party consultant to assist in your data integrity remediation. In response to this letter, provide:
* A comprehensive investigation into the extent of the inaccuracies and inconsistencies in data, records, and reporting. Your investigation should include:
o 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.
o 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.
o 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 deficiencies.
o A comprehensive retrospective evaluation of the nature of the testing data integrity deficiencies. We recommend that a qualified third party with specific expertise in the area where potential breaches were identified should evaluate all occurrences.
* 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 data integrity event and analyses of the risks posed by ongoing operations.
* A management strategy for your firm that includes the details of your global CAPA plan. Your strategy should include:
o A detailed corrective action plan that describes how you intend to ensure the reliability and completeness of all data, including analytical data, manufacturing records, and all data submitted to FDA.
o A comprehensive description of the root causes of each data integrity deviation, 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 the data integrity breaches remain able to influence CGMP-related or drug application data at your firm.
o Interim measures describing the actions you have taken or will take to ensure the quality of your drugs and protect patients, such as notifying your customers, recalling product(s), conducting additional testing, adding lots to your stability programs to assure stability, drug application actions, and enhanced complaint monitoring.
o 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.
o 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.
o 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 an independent quality assurance function, along with expertise from outside entities whenever needed).
o A status report for any of the above activities already underway or completed.
Drug Recall
On September 1, 2026, FDA held a teleconference with you recommending you remove your toothpaste drug products within expiry from the U.S. market.
On September 10, 2026, you issued a voluntary recall of all toothpaste drug products within expiry that were shipped between September 2024 and August 2026 currently in distribution in the United States. This recall included the "Brush Buddies Cookies 'n Cream Ice Cream Flavored Toothpaste" that contained a cancelled color additive.
The recall was posted to the FDA's Enforcement Report website at: https://www.accessdata.fda.gov/scripts/ires/?Event=99849.
Revocation of FD&C Red No. 3
FDA revoked the authorization for the use of FD&C Red No. 3. We recommend manufacturers review their drug product formulations. Manufacturers who use FD&C Red No. 3 in ingested drugs will have until January 18, 2028, to reformulate their products. For more information see https://www.fda.gov/food/hfp-constituent-updates/fda-revoke-authorization-use-red-no-3-food-and-ingested-drugs.
Conclusion
You are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur.
FDA placed all drugs and drug products offered for import into the United States from your firm on Import Alert 66-40 on September 3, 2026.
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 Pritam International Private Limited located at Khasra No. 138, Raipur Industrial Area, Bhagwanpur in Haridwar, India 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).
Send your written response to CDER-OC-OMQ-Communications@fda.hhs.gov within fifteen (15) business days of receipt of this letter. Identify your written response with FEI 3020826443 and ATTN: Frank Wackes in the subject line of the email.
If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration.
FDA posts warning letters to www.FDA.gov.
Sincerely,
/S/ Francis Godwin, Director, Office of Manufacturing Quality, Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration
cc:
Liberty Management Group Ltd., US agent
Email: manoj@libertymanagement.us
Mr. Pratam Singh, Plant Head, Pritam International Private Limited
Email: Pratap@wonderproducts.co.in
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Original text here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pritam-international-private-limited-738079-10272026
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Recipient: Dr. Rahul Mahajan Sr, General Manager Quality, Pritam International Private Limited, Khasra No. 138, Raipur Industrial Area Bhagwanpur, Haridwar 247667 Uttarakhand, India, rahul.mahajan@wonderproducts.co.in
Issuing Office: Center for Drug Evaluation and Research (CDER), United States
WARNING LETTER
Reference number: 320-27-12
To Dr. Rahul Mahajan:
This ... Show Full Article WASHINGTON, Nov. 4 (TNSdock) -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Pritam International Private Limited from its Center for Drug Evaluation and Research: * * * Recipient: Dr. Rahul Mahajan Sr, General Manager Quality, Pritam International Private Limited, Khasra No. 138, Raipur Industrial Area Bhagwanpur, Haridwar 247667 Uttarakhand, India, rahul.mahajan@wonderproducts.co.in Issuing Office: Center for Drug Evaluation and Research (CDER), United States WARNING LETTER Reference number: 320-27-12 To Dr. Rahul Mahajan: Thiswarning letter advises you of significant violations identified during a U.S. Food and Drug Administration (FDA) inspection of your facility and during a review of records submitted from your facility and provides you an opportunity to address them. Promptly address any violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that exist at your facility. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address any violations may result in regulatory action without further notice.
FDA Review
Violations were identified and documented during review of your drug manufacturing facility, Pritam International Private Limited, FDA Establishment Identifier (FEI) 3020826443. This review was conducted under FDA's statutory authority and public health responsibilities to protect the public from unsafe, ineffective, and poor quality drugs.
Your facility is registered with the FDA as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our April 24, 2026, request for records and other information pursuant to section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for your facility.
FDA Inspection
Violations were also identified and documented during an inspection of your drug manufacturing facility, Pritam International Private Limited, FEI 3020826443 from June 2 to 6, 2026. This inspection was conducted under FDA's statutory authority and public health responsibilities to protect the public from unsafe, ineffective, and poor quality drugs.
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 FD&C Act, 21 U.S.C. 351(a)(2)(B).
In addition, your "Brush Buddies Cookies 'n Cream Ice Cream Flavored Toothpaste" is adulterated under section 501(a)(4)(A) as this drug product bears or contains a color additive that is unsafe within the meaning of section 721 of the FD&C Act, 21 U.S.C. 379e. Accordingly, the introduction or delivery for introduction of "Brush Buddies Cookies 'n Cream Ice Cream Flavored Toothpaste" into interstate commerce is a prohibited act under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
We reviewed your May 11, 2026, response to our request for records in detail, and your June 25, 2026, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.
Violations of the Federal Food, Drug, and Cosmetic Act
The following are violations identified during our inspection and our records review. As a reminder, this is not an all-inclusive list of violations at your facility.
Adulterated within the meaning of section 501(a)(4)(A) of the FD&C Act
Your firm contract manufactures OTC toothpaste and (b)(4) drug products for distribution to the U.S. market. Your toothpaste drug products are indicated for use in both children and adults.
Based on our review of batch records and product labels, your "Brush Buddies Cookies 'n Cream Ice Cream Flavored Toothpaste" contains the color additive "CI 14720" (also known as Ext. D&C Red No. 10 or Acid Red No. 14 or Food Red 3 or Carmoisine or Azorubine (E122)). In 1966, FDA cancelled the certification and delisted Ext. D&C Red No. 10 due to lack of safety data from any manufacturer. Under 21 CFR 81.30(d), using Ext. D&C Red No.10 after October 4, 1966, results in the drug being adulterated.
Any color additive not explicitly listed as safe for its intended use is deemed unsafe within the meaning of section 721(a) of the FD&C Act. The inclusion of a delisted color additive in your drug product formulation indicates that your quality unit's review (as required under 21 CFR 211.22) of your raw material qualification process and formulation review procedures are inadequate to ensure that only acceptable ingredients are used in the manufacture of drug products, especially those marketed to children.
In response to this letter, provide:
* A risk assessment to review all your drug formulations to ensure the use of appropriate color additives, including any that may use alternate names. For more information, see the webpage for Regulatory Status of Color Additives at https://www.hfpappexternal.fda.gov/scripts/fdcc/index.cfm?set=ColorAdditives.
Adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act
1. 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)).
You lacked complete and original laboratory data demonstrating that the required testing was performed.
You use (b)(4) as a major component of your drug products. During the inspection, we observed multiple media plates with (b)(4) for (b)(4) samples in your incubator with visible microbiological growth. However, on the next day, during plate reading and result recording, there was no visible microbiological growth on plates labeled as the same samples observed the day before. Additionally, we identified multiple discrepancies between the labeling of the sample identification information handwritten on the exterior of the plates from one day to the subsequent day.
Microbiological monitoring and testing are essential quality control steps that are integral to ensure raw materials are adequate for use. Such programs provide critical information on the state of control of the manufacturing operation. Substitution of unreliable or false results fundamentally compromises a facility's ability to identify risks to the drug product.
In your response, you indicate that an investigation into the falsified results concluded that the "... transposition of plates ..." was a deliberate but isolated act by the microbiologist to circumvent your procedure. You state that you retrained the microbiologists to recognize when a plate should be considered Too Numerous To Count (TNTC), introduced a tamper evident seal for the plate, implemented color coding to differentiate the negative control plate from the product or component sample, and mandated that all microbiological plate reading must be performed by two analysts concurrently prior to data entry.
Your response is inadequate since you fail to address the severity of the observed data integrity violation for the falsification and alteration of the microbiological test results. Your proposed corrective actions address the data integrity breaches as isolated procedural gaps rather than as evidence of a systemic breakdown in quality unit (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.
Microbiological testing, an essential quality control step, is integral in preventing distribution of unsafe products. Integrity of data is fundamentally compromised when there is a failure to record or maintain complete and accurate records of test results or conditions associated with drug testing. Furthermore, the lack of reliable data compromises the QU's ability to exercise its function of ensuring compliance with applicable standards.
In response to this letter, provide:
* A comprehensive, independent assessment of your laboratory practices, procedures, methods, equipment, documentation, supervisory oversight, and analyst competencies. Based on this review, provide a detailed plan to remediate and evaluate the effectiveness of your laboratory system.
* A comprehensive, independent assessment 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 (ALCOA) records throughout your operation.
* A comprehensive CAPA, overseen by a qualified consultant, for handling microbiological sampling media to ensure robust and reliable data. Establish a system that ensures uninterrupted and uncompromised custody, with full reconciliation of all microbiological samples, including but not limited to:
o unique labeling of each sample
o signatures of all staff who handle the sample
o complete tracking of sample integrity and custody
o date and time of each activity (e.g., sample collection, transport, delivery, incubation, removal from incubator)
o digital time-stamped photos of all plates at the time of plate reading
o laboratory tools (e.g., magnification, appropriate light) and methods that optimize visibility and detectability of colonies on plates
o signatures of personnel performing reading of microbial counts
o provisions for verifications and routine quality assurance oversight
2. Your firm failed to conduct at least one test to verify the identity of each component of a drug product. Your firm also failed to validate and establish the reliability of your component supplier's test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)).
You failed to perform adequate identity testing for each component lot used in the production of your OTC drug products. You relied on the certificates of analysis (COAs) from your suppliers and failed to establish the reliability of each of your suppliers' COA for component specifications and characteristics.
Products Contain Ingredients at Risk for Diethylene Glycol or Ethylene Glycol (DEG or EG) Contamination
You manufacture multiple toothpaste drug products (intended for adults and children) that contain sorbitol solution. You failed to adequately test your incoming components at high risk of DEG and EG contamination for identity before using them to manufacture your drug products. For example, during the inspection, you provided our investigators with one COA with independent identity testing results, including DEG and EG, out of approximately (b)(4) shipments of sorbitol solution. Identity testing, including DEG and EG, is required for each lot that you receive.
The use of ingredients contaminated with DEG or EG has resulted in various lethal poisoning incidents in humans worldwide. See FDA's guidance document, Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol, to help you meet the CGMP requirements when manufacturing drugs containing ingredients at high-risk for DEG or EG contamination at https://www.fda.gov/media/167974/download.
In your response, you proposed modifying the receipt of drums and tanker trucks of the sorbitol solution component to perform identity testing prior to use in manufacturing. You also indicated that you would perform destructive testing of all finished drug product reserve (control) samples.
Your response is inadequate. You did not provide any additional evidence that sorbitol solution had been properly tested to confirm identity prior to use. Furthermore, you did not address whether identity testing is performed for other potential high-risk components (such as glycerin and polyethylene glycol).
Without appropriate testing of components and ingredients, you cannot ensure the quality and safety of your drug products. Without adequate testing and confirmation of reliability of supplier and external laboratory testing results, you lack scientific evidence that the components or drug products conform to appropriate specifications.
In response to this letter, provide:
* A commitment to provide DEG and EG test results, no later than 30 calendar days from the date of this letter, from testing retains for all lots of high-risk drug components used in the manufacture of drug products. Alternatively, if a retain of a component lot is unavailable, perform retain sample testing of all implicated finished drug product batches for the presence of DEG and EG.
* A full risk assessment for drug products that are within expiry which contain any ingredient at risk for DEG or EG contamination (including, but not limited to, glycerin). Take prompt and appropriate actions to determine the safety of all lots of the component(s) and any related drug product that could contain DEG or EG, including customer notifications and product recalls for any contaminated lots. Identify additional appropriate CAPA that secure supply chains in the future, including, but not limited to, ensuring that all incoming raw material lots are from fully qualified manufacturers and free from unsafe impurities. Detail these actions in your response to this letter.
* A description of how you will test each component lot for conformity with all appropriate specifications for identity, strength, quality, and purity. If you intend to accept any results from your supplier's COA instead of testing each component lot for strength, quality, and purity, specify how you will robustly establish the reliability of your supplier's results through initial validation as well as periodic revalidation. In addition, include a commitment to always conduct at least one specific identity test for each incoming component lot. In the case of glycerin, propylene glycol, and certain additional high-risk components we note that this includes the performance of parts A, B, and C of the United States Pharmacopeia (USP) monograph.
* The chemical quality control specifications you use to test each incoming lot of high-risk drug components to determine acceptability for use in manufacturing.
* A comprehensive, independent review of your material system to determine whether all suppliers of components, containers, and closures, are each qualified and the materials are assigned appropriate expiration or retest dates. The review should also determine whether incoming material controls are adequate to prevent use of unsuitable components, containers, and closures.
* A summary of results obtained from testing all components to evaluate the reliability of the COA from each component manufacturer. Include your SOP that describes this COA validation program.
3. Your firm's quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).
Your QU failed to exercise its authority and responsibilities over your drug manufacturing operations, including ensuring the data integrity of your records. For example, the QU failed to ensure:
* (b)(4) was suitable for its intended use (21 CFR 211.100).
* An adequate training program for your microbiology laboratory employees that objectively evaluated competency and proficiency results to assess training effectiveness (21 CFR 211.25(c)).
* Adequate laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures (21 CFR 211.160(b)).
For help implementing quality system and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211, see FDA's guidance documents Quality Systems Approach to Pharmaceutical CGMP Regulations at https://www.fda.gov/media/71023/download, as well as ICH Q10 Pharmaceutical Quality System at https://www.fda.gov/media/71553/download.
In response to this letter, provide:
* 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:
o A determination of whether procedures used by your firm are robust and appropriate
o Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices
o A complete and final review of each batch and its related information before the QU disposition decision
o Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products
o Also describe how top management supports quality assurance and reliable operations including, but not limited to, timely provision of resources to proactively address emerging quality issues and to assure a continuing state of control.
* A comprehensive remediation plan for the design, control, and maintenance of the water system, including:
o A comprehensive evaluation of vulnerabilities of water system design and control and summarize all deficiencies found in the system. The summary should, at minimum, describe various system characteristics that were assessed for adequacy (system temperature, materials of construction, slope, any identified dead-legs, any stagnant locations, any unsanitary fittings, flow velocity, etc.)
* Your total microbiological count limits to monitor whether this system produces water suitable for the intended uses for each of your products.
* A detailed risk assessment addressing the potential effects of the observed water system failures on the quality of all drug product lots currently in U.S. distribution. Specify actions that you will take in response to the risk assessment, such as customer notifications and product recalls.
CGMP Consultant Recommended
Based upon the nature of the violations we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 211.34 to evaluate your operations and to assist your firm in meeting CGMP requirements if your firm intends to resume manufacturing drugs for the U.S. market. The qualified consultant should also perform a comprehensive six-system audit of your entire operation for CGMP compliance and evaluate the completion and efficacy of your CAPA before you pursue resolution of your firm's compliance status with FDA.
Your use of a consultant does not relieve your firm's obligation to comply with CGMP. Your firm's executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.
Data Integrity Remediation
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, qualified third-party consultant to assist in your data integrity remediation. In response to this letter, provide:
* A comprehensive investigation into the extent of the inaccuracies and inconsistencies in data, records, and reporting. Your investigation should include:
o 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.
o 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.
o 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 deficiencies.
o A comprehensive retrospective evaluation of the nature of the testing data integrity deficiencies. We recommend that a qualified third party with specific expertise in the area where potential breaches were identified should evaluate all occurrences.
* 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 data integrity event and analyses of the risks posed by ongoing operations.
* A management strategy for your firm that includes the details of your global CAPA plan. Your strategy should include:
o A detailed corrective action plan that describes how you intend to ensure the reliability and completeness of all data, including analytical data, manufacturing records, and all data submitted to FDA.
o A comprehensive description of the root causes of each data integrity deviation, 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 the data integrity breaches remain able to influence CGMP-related or drug application data at your firm.
o Interim measures describing the actions you have taken or will take to ensure the quality of your drugs and protect patients, such as notifying your customers, recalling product(s), conducting additional testing, adding lots to your stability programs to assure stability, drug application actions, and enhanced complaint monitoring.
o 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.
o 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.
o 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 an independent quality assurance function, along with expertise from outside entities whenever needed).
o A status report for any of the above activities already underway or completed.
Drug Recall
On September 1, 2026, FDA held a teleconference with you recommending you remove your toothpaste drug products within expiry from the U.S. market.
On September 10, 2026, you issued a voluntary recall of all toothpaste drug products within expiry that were shipped between September 2024 and August 2026 currently in distribution in the United States. This recall included the "Brush Buddies Cookies 'n Cream Ice Cream Flavored Toothpaste" that contained a cancelled color additive.
The recall was posted to the FDA's Enforcement Report website at: https://www.accessdata.fda.gov/scripts/ires/?Event=99849.
Revocation of FD&C Red No. 3
FDA revoked the authorization for the use of FD&C Red No. 3. We recommend manufacturers review their drug product formulations. Manufacturers who use FD&C Red No. 3 in ingested drugs will have until January 18, 2028, to reformulate their products. For more information see https://www.fda.gov/food/hfp-constituent-updates/fda-revoke-authorization-use-red-no-3-food-and-ingested-drugs.
Conclusion
You are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur.
FDA placed all drugs and drug products offered for import into the United States from your firm on Import Alert 66-40 on September 3, 2026.
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 Pritam International Private Limited located at Khasra No. 138, Raipur Industrial Area, Bhagwanpur in Haridwar, India 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).
Send your written response to CDER-OC-OMQ-Communications@fda.hhs.gov within fifteen (15) business days of receipt of this letter. Identify your written response with FEI 3020826443 and ATTN: Frank Wackes in the subject line of the email.
If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration.
FDA posts warning letters to www.FDA.gov.
Sincerely,
/S/ Francis Godwin, Director, Office of Manufacturing Quality, Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration
cc:
Liberty Management Group Ltd., US agent
Email: manoj@libertymanagement.us
Mr. Pratam Singh, Plant Head, Pritam International Private Limited
Email: Pratap@wonderproducts.co.in
* * *
Original text here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pritam-international-private-limited-738079-10272026
FDA Center for Drug Evaluation & Research Issues Warning Letter to New York Tong Ren Tang
WASHINGTON, Nov. 4 (TNSdock) -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Jing Cheong Asia Inc. dba New York Tong Ren Tang from its Center for Drug Evaluation and Research:
* * *
Recipient: Timothy Chuang, Chief Executive Officer, Jing Cheong Asia Inc. dba New York Tong Ren Tang, 4034 Main Street, Flushing, NY 11354, United States, help@nytrt.com
Issuing Office: Center for Drug Evaluation and Research (CDER), United States
WARNING LETTER
Reference Number: 738200
To Timothy Chuang:
This warning letter advises you of ... Show Full Article WASHINGTON, Nov. 4 (TNSdock) -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Jing Cheong Asia Inc. dba New York Tong Ren Tang from its Center for Drug Evaluation and Research: * * * Recipient: Timothy Chuang, Chief Executive Officer, Jing Cheong Asia Inc. dba New York Tong Ren Tang, 4034 Main Street, Flushing, NY 11354, United States, help@nytrt.com Issuing Office: Center for Drug Evaluation and Research (CDER), United States WARNING LETTER Reference Number: 738200 To Timothy Chuang: This warning letter advises you ofsignificant violations observed during a U.S. Food and Drug Administration (FDA) review of your website, https://nytrt.com/, and provides you an opportunity to address them. Promptly address any violations described herein without delay, including ensuring that appropriate resources are allocated to fully address them and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that may exist in connection with your products or operations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address any violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.
Your "Ofloxacin Eye Drops" product discussed below is especially concerning from a public health perspective. Ophthalmic drug products, which are intended for administration into the eyes, in general pose a greater risk of harm to users because the route of administration for these products bypasses some of the body's natural defenses.
FDA Review
Violations were identified and documented during a review of your website https://nytrt.com/ in September 2026. Based on our review, "Ofloxacin Eye Drops," "Jingzhi Niuhuang Jiedu Pian," and "Gui Pi Wan" are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering these products for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).
This review was conducted as part of FDA's public health responsibility to protect the public from unsafe, ineffective, and poor-quality drugs.
Violations of the Federal Food, Drug, and Cosmetic Act
The following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations that may exist in connection with your products or operations.
Unapproved New Drug Violations
Based on a review of your website, "Ofloxacin Eye Drops," "Jingzhi Niuhuang Jiedu Pian," and "Gui Pi Wan" are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body. Examples from your product labeling, including on your website, that provide evidence of the intended use (as defined in 21 CFR 201.128) of these products as drugs include, but may not be limited to, the following:
Ofloxacin Eye Drops
On the webpage https://nytrt.com/products/ofloxacin-eye-drops-5ml (translated from Chinese):
* "This product is indicated for external ocular infections, including bacterial conjunctivitis, keratitis, corneal ulcers, dacryocystitis, and post-operative infections."
Jingzhi Niuhuang Jiedu Pian
On the webpage https://nytrt.com/products/jingzhi-niuhuang-jiedu-pian-cholinex?_pos=5&_sid=6791608a5&_ss=r:
* "May assist with high fever aggravated by constipation. May be useful in treating children's fever, including fevers due to measles, mumps, and tonsillitis."
Gui Pi Wan
On the webpage https://nytrt.com/products/gui-pi-wan-240pills?_pos=3&_sid=8a48de578&_ss=r:
* "For heart shen disorders due to deficiency of qi and blood, poor memory, excessive dreaming, dizziness, palpitations, or anxiety. Use for blood deficiency disorders including aplastic anemia and thrombocytopenic purpura."
"Ofloxacin Eye Drops," "Jingzhi Niuhuang Jiedu Pian," and "Gui Pi Wan" are "new drugs" under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in their labeling. With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these products. Accordingly, these products are unapproved new drugs. The introduction or delivery for introduction into interstate commerce of these unapproved new drug products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).
We also observed that your website https://nytrt.com offers "Notoginseng Formula Special Gout Granule" for sale to consumers in the United States. Previous FDA lab analyses of the product similarly named to "Notoginseng Formula Special Gout Granule" sold on your website revealed the product contained undeclared drug ingredients.1 While the Agency has not sampled and tested this product variation from your inventory to date, this letter expresses our serious concern about the safety of this product. We emphasize that it is your legal responsibility under federal law to ensure that products you sell do not contain any undeclared or potentially harmful ingredients, and that they are marketed in compliance with applicable laws.
Conclusion
As previously stated, you are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur.
Send your written response to FDAAdvisory@fda.hhs.gov within fifteen (15) business days of receipt of this letter. Include the specific steps you have taken to correct any violations, an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration. Identify your response with reference number "738200" in the subject line of the email.
Please note FDA posts warning letters on www.fda.gov.
Sincerely,
/S/ Tina Smith, M.S., Captain, U.S. Public Health Service, Director, Office of Unapproved Drugs and Labeling Compliance, Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration
* * *
Footnote:
1/ See https://www.fda.gov/drugs/medication-health-fraud/notoginseng-formula-special-gout-granule-contains-hidden-drug-ingredients.
* * *
Original text here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/jing-cheong-asia-inc-dba-new-york-tong-ren-tang-738200-10262026
* * *
Recipient: Timothy Chuang, Chief Executive Officer, Jing Cheong Asia Inc. dba New York Tong Ren Tang, 4034 Main Street, Flushing, NY 11354, United States, help@nytrt.com
Issuing Office: Center for Drug Evaluation and Research (CDER), United States
WARNING LETTER
Reference Number: 738200
To Timothy Chuang:
This warning letter advises you of ... Show Full Article WASHINGTON, Nov. 4 (TNSdock) -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Jing Cheong Asia Inc. dba New York Tong Ren Tang from its Center for Drug Evaluation and Research: * * * Recipient: Timothy Chuang, Chief Executive Officer, Jing Cheong Asia Inc. dba New York Tong Ren Tang, 4034 Main Street, Flushing, NY 11354, United States, help@nytrt.com Issuing Office: Center for Drug Evaluation and Research (CDER), United States WARNING LETTER Reference Number: 738200 To Timothy Chuang: This warning letter advises you ofsignificant violations observed during a U.S. Food and Drug Administration (FDA) review of your website, https://nytrt.com/, and provides you an opportunity to address them. Promptly address any violations described herein without delay, including ensuring that appropriate resources are allocated to fully address them and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that may exist in connection with your products or operations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address any violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.
Your "Ofloxacin Eye Drops" product discussed below is especially concerning from a public health perspective. Ophthalmic drug products, which are intended for administration into the eyes, in general pose a greater risk of harm to users because the route of administration for these products bypasses some of the body's natural defenses.
FDA Review
Violations were identified and documented during a review of your website https://nytrt.com/ in September 2026. Based on our review, "Ofloxacin Eye Drops," "Jingzhi Niuhuang Jiedu Pian," and "Gui Pi Wan" are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering these products for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).
This review was conducted as part of FDA's public health responsibility to protect the public from unsafe, ineffective, and poor-quality drugs.
Violations of the Federal Food, Drug, and Cosmetic Act
The following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations that may exist in connection with your products or operations.
Unapproved New Drug Violations
Based on a review of your website, "Ofloxacin Eye Drops," "Jingzhi Niuhuang Jiedu Pian," and "Gui Pi Wan" are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body. Examples from your product labeling, including on your website, that provide evidence of the intended use (as defined in 21 CFR 201.128) of these products as drugs include, but may not be limited to, the following:
Ofloxacin Eye Drops
On the webpage https://nytrt.com/products/ofloxacin-eye-drops-5ml (translated from Chinese):
* "This product is indicated for external ocular infections, including bacterial conjunctivitis, keratitis, corneal ulcers, dacryocystitis, and post-operative infections."
Jingzhi Niuhuang Jiedu Pian
On the webpage https://nytrt.com/products/jingzhi-niuhuang-jiedu-pian-cholinex?_pos=5&_sid=6791608a5&_ss=r:
* "May assist with high fever aggravated by constipation. May be useful in treating children's fever, including fevers due to measles, mumps, and tonsillitis."
Gui Pi Wan
On the webpage https://nytrt.com/products/gui-pi-wan-240pills?_pos=3&_sid=8a48de578&_ss=r:
* "For heart shen disorders due to deficiency of qi and blood, poor memory, excessive dreaming, dizziness, palpitations, or anxiety. Use for blood deficiency disorders including aplastic anemia and thrombocytopenic purpura."
"Ofloxacin Eye Drops," "Jingzhi Niuhuang Jiedu Pian," and "Gui Pi Wan" are "new drugs" under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in their labeling. With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these products. Accordingly, these products are unapproved new drugs. The introduction or delivery for introduction into interstate commerce of these unapproved new drug products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).
We also observed that your website https://nytrt.com offers "Notoginseng Formula Special Gout Granule" for sale to consumers in the United States. Previous FDA lab analyses of the product similarly named to "Notoginseng Formula Special Gout Granule" sold on your website revealed the product contained undeclared drug ingredients.1 While the Agency has not sampled and tested this product variation from your inventory to date, this letter expresses our serious concern about the safety of this product. We emphasize that it is your legal responsibility under federal law to ensure that products you sell do not contain any undeclared or potentially harmful ingredients, and that they are marketed in compliance with applicable laws.
Conclusion
As previously stated, you are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur.
Send your written response to FDAAdvisory@fda.hhs.gov within fifteen (15) business days of receipt of this letter. Include the specific steps you have taken to correct any violations, an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration. Identify your response with reference number "738200" in the subject line of the email.
Please note FDA posts warning letters on www.fda.gov.
Sincerely,
/S/ Tina Smith, M.S., Captain, U.S. Public Health Service, Director, Office of Unapproved Drugs and Labeling Compliance, Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration
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Footnote:
1/ See https://www.fda.gov/drugs/medication-health-fraud/notoginseng-formula-special-gout-granule-contains-hidden-drug-ingredients.
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Original text here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/jing-cheong-asia-inc-dba-new-york-tong-ren-tang-738200-10262026