Wednesday, January 4, 2023
| MD Pharmaceutical Supply, LLC | Division of Pharmaceutical Quality Operations I | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | |||
| VapeL1FE, LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||
| Mike Millenkamp Dairy Cattle | Division of Human and Animal Food Operations West II | New Animal Drug/Adulterated | |||
| Supreme Fruit Produce, Inc. | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) |
| Superior Glove Works, Ltd. | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated | |||
| globalpharmacyplus.com | Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet | ||||
| EarthLab, Inc., dba Wise Woman Herbals | Division of Human and Animal Food Operations West VI | CGMP/Dietary Supplement/Adulterated/Misbranded | |||
| Big Olaf Creamery LLC dba Big Olaf | Division of Human and Animal Food Operations East IV | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes | |||
| Ruth Special Food Store LLC | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) | |||
| Empowered Diagnostics LLC | Center for Devices and Radiological Health | Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) | |||
| RoyalVibe Health Ltd. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/PMA/Adulterated/Misbranded | |||
| Bainbridge Beverage West, LLC | Division of Human and Animal Food Operations West V | Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | |||
| Land View, Inc. | Division of Human and Animal Food Operations West VI | CGMP/Medicated Feeds/Adulterated | |||
| Green Pharmaceuticals Inc. | Division of Pharmaceutical Quality Operations IV | Drug Product/Adulterated |
Collegeville Man Found Guilty for Scheme to Sell Fraudulent Canine Cancer-Curing Drugs to Pet Owners The defendant promised to restore the health of terminally ill dogs and defrauded 900 pet owners of nearly one million dollars altogether
Collegeville Man Found Guilty for Scheme to Sell Fraudulent Canine Cancer-Curing Drugs to Pet Owners
The defendant promised to restore the health of terminally ill dogs and defrauded 900 pet owners of nearly one million dollars altogether
PHILADELPHIA – United States Attorney Jacqueline C. Romero announced that Jonathan Nyce, 73, of Collegeville, PA, was convicted by a federal jury of wire fraud and the interstate shipment of misbranded animal drugs. The charges arise from a years-long scheme to defraud pet owners of money by falsely claiming to sell canine cancer-curing drugs.
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Wednesday, December 28, 2022
| Ruth Special Food Store LLC | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) | ||||
| Mike Millenkamp Dairy Cattle | Division of Human and Animal Food Operations West II | New Animal Drug/Adulterated |
| EarthLab, Inc., dba Wise Woman Herbals | Division of Human and Animal Food Operations West VI | CGMP/Dietary Supplement/Adulterated/Misbranded | ||||
| Big Olaf Creamery LLC dba Big Olaf | Division of Human and Animal Food Operations East IV | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes | ||||
| Ruth Special Food Store LLC | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) | ||||
| Empowered Diagnostics LLC | Center for Devices and Radiological Health | Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) | ||||
| RoyalVibe Health Ltd. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/PMA/Adulterated/Misbranded | ||||
| Bainbridge Beverage West, LLC | Division of Human and Animal Food Operations West V | Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | ||||
| Land View, Inc. | Division of Human and Animal Food Operations West VI | CGMP/Medicated Feeds/Adulterated | ||||
| Green Pharmaceuticals Inc. | Division of Pharmaceutical Quality Operations IV | Drug Product/Adulterated | ||||
| MD Pharmaceutical Supply, LLC | Division of Pharmaceutical Quality Operations I | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | ||||
| VapeL1FE, LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Thursday, December 22, 2022
District Court Orders Oklahoma Drug Compounder in Edmond Oklahoma to Comply with Federal Food, Drug, and Cosmetic Act
Department of Justice
Office of Public Affairs
FOR IMMEDIATE RELEASE
Monday, December 19, 2022
District Court Orders Oklahoma Drug Compounder to Comply with Federal Food, Drug, and Cosmetic Act
A federal court today issued an order prohibiting Qualgen LLC, an Oklahoma company, Shaun P. Riney, Qualgen’s Chief Executive Officer, and Jasen Lavoie, Qualgen’s Director of Quality, from manufacturing and distributing drugs that are not in compliance with the Federal Food, Drug, and Cosmetic Act (FDCA).
In a civil complaint filed on Dec. 6, the United States alleged that Qualgen, Riney, and Lavoie violated the FDCA at the company’s facilities in Edmond, Oklahoma, by manufacturing and distributing adulterated drugs. As an outsourcing facility registered with the U.S. Food and Drug Administration (FDA), Qualgen makes and distributes sterile drug products, including Bio-Identical Hormone Replacement Therapy pellets (testosterone, estradiol, and testosterone/anastrozole). The United States alleged that the defendants violated the FDCA by, among other things, failing to follow written procedures applicable to the quality control unit, failing to reject drug products that did not meet specifications, and failing to follow appropriate procedures in handling complaints about its drug products. The complaint also alleged that the FDA inspected the company’s facilities five times, in 2015, 2017, 2018, 2021, and 2022, and that many of the violations were repeat violations the FDA had identified in earlier inspections.
The FDCA’s current good manufacturing practice regulations mandate that manufacturers control the processes and procedures by which their drugs are manufactured, processed, packed, and held, to ensure that the drugs have the identity, strength, quality, purity, and other attributes necessary for their safe and effective use. Drugs not made in conformance with current good manufacturing practice regulations are deemed adulterated under the FDCA. According to the United States’ complaint, the FDA issued Qualgen several warnings, including during meetings with the FDA and in a warning letter to the company in 2016, regarding alleged deficiencies at its facilities.
“Drugs compounded in outsourcing facilities must be manufactured in conformance with applicable regulations,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “The Department of Justice will continue to work closely with the FDA and take action against compounding drug manufacturers who fail to abide by laws designed to protect public health.”
“Failure to manufacture drugs in strict compliance with FDA requirements endangers the very people who need and rely on the quality of those medications,” said U.S. Attorney Robert J. Troester for the Western District of Oklahoma. “We gladly partner with the FDA to enforce their regulations in order to ensure public safety is maintained in the pharmaceutical manufacturing and compounding process.”
“While drugs compounded by outsourcing facilities are not subject to pre-market review and approval by the FDA for safety and effectiveness, they must comply with rigorous manufacturing quality assurance requirements,” said Acting Director Jill P. Furman, J.D. of the FDA’s Center for Drug Evaluation and Research Office of Compliance. “The FDA’s commitment to ensuring compliance with current good manufacturing practice requirements is a critical protection for patients. We will remain vigilant and hold all manufacturers accountable to best protect the public health.”
Without admitting or denying the allegations in the complaint, the defendants agreed to settle the suit and be bound by a consent decree of permanent injunction. The negotiated consent decree entered by the court permanently enjoins the defendants from violating the FDCA, and prohibits, among other things, the defendants from manufacturing, compounding, processing, labeling, holding, or distributing adulterated drugs.
Senior Trial Attorney Natalie N. Sanders of the Justice Department’s Consumer Protection Branch and Assistant U.S. Attorney Ronald R. Gallegos for the Western District of Oklahoma handled this matter, with the assistance of Senior Counsel Paige H. Taylor of the FDA’s Office of the Chief Counsel.
Additional information about the Consumer Protection Branch and its enforcement efforts may be found at http://www.justice.gov/civil/consumer-protection-branch.
The claims resolved by the resolution announced today are allegations only and there has been no determination of liability.
Updated December 19, 2022
| Nature’s Way Farms, LLC | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) | ||||
| Nortec Quimica SA | Center for Drug Evaluation and Research | CDER | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | ||||
| CHS Inc./CHS River Plains | Division of Human and Animal Food Operations West I | CGMP/Medicated Feeds/Adulterated | ||||
| DuPont Nutrition USA Inc. | Division of Pharmaceutical Quality Operations I | CGMP/Drug Products/Adulterated | ||||
| Del Valle Import Corp. | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) | ||||
| Sree Nidhi Corp | Center for Food Safety and Applied Nutrition (CFSAN) | Foreign Supplier Verification Program (FSVP) | ||||
| Adarsh Daswani, M.D. | Center for Drug Evaluation and Research | CDER | Clinical Investigator | ||||
| Dollar Tree, Inc. | Office of Human and Animal Food Operations – West Division 3 | Interstate Commerce/Food/Adulterated | ||||
| Sagent Pharmaceuticals, Inc. | Division Pharmaceutical Quality Operations I | CGMP/Drugs/Adulterated |
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