Inspections, Compliance, Enforcement, and Criminal Investigations

2019 Warning Letters

Letter Issue Date Company Name Issuing Office Subject Close Out Date
02/13/2019 Mark Berman, M.D. Los Angeles District Office Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Not Issued *
02/11/2019 Bella Pharmaceuticals, Inc. Detroit District Office Compounding Pharmacy/Adulterated Drug Products Not Issued *
02/11/2019 United Pharmacy Dallas District Office Compounding Pharmacy/Adulterated Drug Products Not Issued *
02/07/2019 McKesson Corporation Headquarters Office of Regulatory Affairs Drug Product/Adulterated Not Issued *
02/06/2019 Datascope Corp. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
02/05/2019 John Gray’s Mars Venus LLC Center for Food Safety and Applied Nutrition New Drug/Labeling/Misbranded Not Issued *
02/05/2019 Triad Rx, Inc Dallas District Office Compounding Pharmacy/Adulterated Drug Products Not Issued *
02/05/2019 TEK Naturals Center for Food Safety and Applied Nutrition New Drug/Labeling/Misbranded Not Issued *
02/05/2019 Pure Nootropics, LLC Center for Food Safety and Applied Nutrition New Drug/Labeling/Misbranded Not Issued *
02/05/2019 Capris Associates Inc. / BR Naturals Center for Food Safety and Applied Nutrition New Drug/Labeling/Misbranded Not Issued *
02/05/2019 Nutrition Coalition Inc Center for Food Safety and Applied Nutrition New Drug/Labeling/Misbranded Not Issued *
02/05/2019 Gold Crown Natural Products Center for Food Safety and Applied Nutrition New Drug/Labeling/Misbranded Not Issued *
02/05/2019 Sovereign Laboratories, LLC Center for Food Safety and Applied Nutrition New Drug/Labeling/Misbranded Not Issued *
02/05/2019 Earth Turns, LLC Center for Food Safety and Applied Nutrition New Drug/Labeling/Misbranded Not Issued *
02/05/2019 DK Vitamins Center for Food Safety and Applied Nutrition New Drug/Labeling/Misbranded Not Issued *
02/05/2019 Emmbros Overseas Lifestyle PVT LTD. Center for Food Safety and Applied Nutrition New Drug/Labeling/Misbranded Not Issued *
02/05/2019 Peak Nootropics LLC (aka Advanced Nootropics) Center for Food Safety and Applied Nutrition New Drug/Labeling/Misbranded Not Issued *
02/05/2019 Blue Ridge Silver Center for Food Safety and Applied Nutrition New Drug/Labeling/Misbranded Not Issued *
02/04/2019 Akorn, Inc. Detroit District Office CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
02/01/2019 Panther James LLC. Center for Food Safety and Applied Nutrition Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
01/31/2019 LC Medical Concepts, Inc New England District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
01/29/2019 Hangzhou SunKing Nonwovens Co., Ltd. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
01/29/2019 Vipor Chemicals Private Ltd. Center for Drug Evaluation and Research Vipor Chemicals Private Ltd., CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Not Issued *
01/28/2019 Circulatory Technology Inc New England District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
01/10/2019 Vitalab Pharmacy, Inc. Center for Drug Evaluation and Research Drug Product/Adulterated Not Issued *
01/08/2019 Lymol Medical Corp Center for Drug Evaluation and Research Postmarket Requirements (PMRs)  Not Issued *
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Page Last Updated: 02/20/2019
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