FDA hits Zhejiang Tianyu Pharmaceutical with a warning letter after the Chinese drugmaker failed to address prior manufacturing problems.
Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Thursday, September 29, 2022
Ecig Vapor Juice Store | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||||
System Kosmetik Produktionsgesellschaft fur kosmetische Gmbh | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated | ||||
Mena Produce LLC | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) | ||||
El Salvador Products Inc | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) | ||||
Med Pen Concepts, LLC | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated/Misbranded | ||||
Vapeoholic LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||||
GN Tobacco Sweden AB d/b/a White Fox USA | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||||
Muscle Sports Products, LLC | Office of Human and Animal Food Operations East – Division 1 | Unapproved New Drugs/Misbranded | ||||
Zhejiang Tianyu Pharmaceutical Co., Ltd. | Center for Drug Evaluation and Research | CDER | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated |
Tuesday, September 27, 2022
New book recounts the FDA’s ‘unholy birth’ By Erin Blakemore September 26, 2022 at 7:12 a.m. EDT
"Sekeres writes about everything from the FDA’s painstaking 1937 search for remaining bottles of a deadly elixir with antifreeze in it to the agency’s 1962 demand that drugs be both safe and effective to be marketed in the United States."
https://www.washingtonpost.com/wellness/2022/09/26/fda-drug-safety-history/
Thursday, September 22, 2022
Texas Longhorn RX, LLC | Office of Pharmaceutical Quality Operations, Division II | Compounding Pharmacy/Adulterated Drug Products |
Saturday, September 10, 2022
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