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
Friday, September 30, 2022
Thursday, September 29, 2022
FDA hits Zhejiang Tianyu Pharmaceutical with a warning letter after the Chinese drugmaker failed to address prior manufacturing problems.
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 |