Tuesday, March 26, 2024
Sentara Enterprises dba Sentara Infusion Services, Charlottesville VA
- State Referral Letter Issued 01/26/2024 (PDF - 230KB)
| ivsupplyclinic.com | Center for Drug Evaluation and Research | CDER | Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet |
| Fresenius Kabi AG | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | |||
| Innovative Formulations, LLC dba Insane Labz | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded | |||
| Thai Nakorn Patana Co., Ltd. | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated | |||
| Barsotti Juice Company, Inc. | Division of Human and Animal Food Operations West V | Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | |||
| Native Salts LLC | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded | |||
| Gilster-Mary Lee Corporation | Division of Human and Animal Food Operations East VI | Food Labeling/Misbranded | |||
| Bell International Laboratories, Inc. | Division of Pharmaceutical Quality Operations III | CGMP/Finished Pharmaceuticals/Adulterated | |||
| Agila Corporation dba Woody’s Pet Food Deli | Division of Human and Animal Food Operations West I | CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food for Animals (PCAF)/Adulterated | |||
| Colgin, Inc. | Division of Pharmaceutical Quality Operations II | CGMP/Finished Pharmaceuticals/Adulterated | |||
| Dream Wholesale, Inc | Division of Northern Border Imports | Foreign Supplier Verification Program (FSVP) |
| Cosmetic Specialty Labs, Inc. | Division of Pharmaceutical Quality Operations II | CGMP/Finished Pharmaceuticals/Adulterated | |||
| Fresenius Kabi AG | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated |
| Nobles Medical Technology II, Inc. | Center for Devices and Radiological Health | Investigational Review Board (IRB) | |||
| Boehringer Ingelheim Animal Health USA | Center for Veterinary Medicine | False & Misleading Claims/Misbranded | |||
| Spirochaete Research Labs, LLC aka Scitus Laboratory Products | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded | |||
| Human Microbes | Center for Biologics Evaluation and Research (CBER) | CGMP/Deviations/Biologics License Application (BLA) |
| Dermal Source, Inc. | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded | |||
| Indelicare DBA INKEEZE | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded | |||
| Tattoo Numbing Cream Co. | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded | |||
| Wagco Distribution, Inc. | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||
| Jiangsu Shenli Medical Production Co., Ltd. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/PMA/Adulterated/Misbranded | |||
| Sol-Millennium Medical, Inc. | Division of Medical Device and Radiological Health Operations Central | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device | |||
| Medline Industries, LP | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/PMA/Adulterated/Misbranded | |||
| Furst-McNess Company | Division of Human and Animal Food Operations West I | CGMP/Medicated Feeds/Adulterated | |||
| Skull Smash LLC | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
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