Recent Release of August 2024 USFDA Compliance Notices

Issued On Dated Company Department Focus Area
08/06/2024 07/23/2024 Omega Tech Labs LLC Pharmaceutical Quality Operations Dept. IV CGMP/Finished Drugs/Adulterated/Unapproved
08/06/2024 08/01/2024 Guangzhou Baiyunshan Pharmaceutical CDER CGMP/Finished Drugs/Adulterated
08/06/2024 07/17/2024 Velocity Pharma LLC CDER CGMP/Finished Drugs/Adulterated
08/06/2024 07/16/2024 La Parcela Produce LLC Northern Border Imports Division Foreign Supplier Verification (FSVP)
08/06/2024 07/08/2024 High Quality Organics, Inc. Food Operations Dept. V CGMP/Food/Unhygienic Conditions/Adulterated
08/07/2024 08/06/2024 Alohma LLC/Kure CBD & Vape Tobacco Products Center Tobacco Prevention Act/Misbranded
08/12/2024 08/12/2024 Dream Vapor LLC Tobacco Products Center Tobacco Prevention Act/Adulterated/Misbranded
08/13/2024 06/27/2024 Baylab USA, LLC Infection Control Devices Office Investigational Device Exemptions/Adulterated Device
08/13/2024 07/15/2024 Globus Medical, Inc. Medical Device Division I CGMP/QSR/Devices/Adulterated
08/13/2024 08/05/2024 LS Promotions Inc. Pharmaceutical Quality Operations Dept. I CGMP/Finished Drugs/Adulterated
08/13/2024 05/29/2024 Konrad Rejdak, M.D., Ph.D. CBER Bioresearch Monitoring/IRB
08/13/2024 07/10/2024 Central Admixture Pharmacy Services, Inc. Pharmaceutical Quality Operations Dept. IV Compounding/Adulterated Drugs
08/13/2024 07/24/2024 Txsyn Int. LLC Food Operations Dept. III CGMP/Dietary Supplements/Adulterated
08/13/2024 07/11/2024 Nowrez & Ismail Shukri Company CDER CGMP/Finished Drugs/Adulterated
08/13/2024 07/31/2024 BullyKamp Products LLC Veterinary Medicine Center Unapproved Animal Drugs
08/13/2024 07/31/2024 Top Dog Pet Store LLC/The Bulldog Cartel Veterinary Medicine Center Unapproved Animal Drugs
08/15/2024 08/09/2024 AUSTROFOOD S.A.S. CFSAN CGMP/Food/Unsanitary/Adulterated
08/20/2024 08/15/2024 Intercos Europe S.p.A CDER CGMP/Finished Drugs/Adulterated
08/20/2024 07/31/2024 P&L Bean Sprout Farm Food Operations Dept. East II Food/Unsanitary/Adulterated
08/20/2024 08/12/2024 Virtue Vapes Tobacco Products Center Tobacco Prevention Act/Adulterated/Misbranded
08/20/2024 08/15/2024 Eugia Pharma Specialities Limited CDER CGMP/Finished Drugs/Adulterated
08/20/2024 08/15/2024 Media Networks Sydney Pty Limited CDER Failure to Register and List
08/27/2024 08/05/2024 Anglo Freight USA Inc. North Border Imports Division Foreign Supplier Verification
08/27/2024 06/28/2024 Berkeley Biologics, LLC (Formerly Elutia, Inc.) CBER Deviations/Regulations for HCT/Ps
08/27/2024 08/16/2024 V3Beyond, Inc./Beyond Vape Tobacco Products Center Tobacco Prevention Act/Misbranded
08/27/2024 07/29/2024 1 Stop Chicken Health Shop Veterinary Medicine Center Unapproved Animal Drugs
08/27/2024 08/16/2024 Turning Point Brands/VaporFi Tobacco Products Center Tobacco Prevention Act/Misbranded
08/27/2024 08/16/2024 Apollo Future Technology, Inc. Tobacco Products Center Tobacco Prevention Act/Misbranded
08/27/2024 08/07/2024 J. Moniz Company Inc. Northeast Imports Division Seafood HACCP/Unsanitary/Adulterated
08/27/2024 07/12/2024 EyePoint Pharmaceuticals, Inc. Pharmaceutical Quality Operations Div. I CGMP/Drugs/Adulterated
08/27/2024 08/20/2024 AnuMed International, LLC CDER Pharmaceutical/Unapproved/Adulterated/Misbranded
08/27/2024 07/23/2024 Minland of Texas, Inc. Southwest Imports Division Foreign Supplier Verification
08/27/2024 07/26/2024 CARsgen Therapeutics Corporation CBER CGMP/Finished Drugs/Adulterated
08/28/2024 08/07/2024 Adventure Innovations LLC Radiological Health Center Investigational Device Exemptions/Adulterated Device
08/28/2024 08/07/2024 Natures Pillows, Inc. and Top Dog Direct, LLC Radiological Health Center Investigational Device Exemptions/Adulterated Device
08/28/2024 08/07/2024 LEEL Tech Radiological Health Center Investigational Device Exemptions/Adulterated Device
08/28/2024 08/08/2024 Shenzhen Moyeah Technology Co. Radiological Health Center Investigational Device Exemptions/Adulterated Device
08/29/2024 08/29/2024 Favorite Daughter, LLC/Phoenix Vapor Tobacco Products Center Tobacco Prevention Act/Adulterated/Misbranded
08/29/2024 08/29/2024 Vape On LLC/Imperial Vapor Tobacco Products Center Tobacco Prevention Act/Misbranded