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 |
Saturday, September 10, 2022
Horse Doping Seller Sentenced To 42 Months In Manhattan Federal Court Lisa Giannelli Sentenced to 42 Months in Prison
Horse Doping Seller Sentenced To 42 Months In Manhattan Federal Court
Lisa Giannelli Sentenced to 42 Months in Prison
Damian Williams, the United States Attorney for the Southern District of New York, announced that defendant LISA GIANNELLI, received a sentence of 42 months in prison today for her role in an approximately 20-year scheme to sell and distribute to racehorse trainers and others in the racehorse industry “untestable” performance enhancing drugs (“PEDs”) for use in professional horseracing. GIANNELLI was one of over 30 defendants charged in four separate cases in March 2020, each arising from this Office’s multi-year investigation of the abuse of racehorses through the use of performance enhancing drugs.
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Wednesday, September 7, 2022
| Mercado Hispano Distributors, LLC | Division of Southeast Imports | Foreign Supplier Verification Program (FSVP) | ||||
| Mina Global Trading Corp | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) | ||||
| Jones Affiliated Inc. | Division of West Coast Imports | Foreign Supplier Verification Program (FSVP) |
| Mexia Pallets LLC | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) | ||||
| Visvita Corporation | Division of West Coast Imports | Foreign Supplier Verification Program (FSVP) | ||||
| Mercado Hispano Distributors, LLC | Division of Southeast Imports | Foreign Supplier Verification Program (FSVP) | ||||
| Mina Global Trading Corp | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) | ||||
| Blue Stone Import USA Inc. | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) | ||||
| Jones Affiliated Inc. | Division of West Coast Imports | Foreign Supplier Verification Program (FSVP) |
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