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 |