Inspections, Compliance, Enforcement, and Criminal Investigations

2017 Warning Letters

Letter Issue Date Company Name Issuing Office Subject Close Out Date
12/29/2017 PT. GALAXY NUSA DUA Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
12/29/2017 PT. Nusantara Jaya Abadi Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
12/29/2017 Transbuana International Express Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
12/28/2017 Investra-24hs Center for Drug Evaluation and Research Finished Pharmaceuticals/Unapproved New Drug/Misbranded Not Issued *
12/21/2017 Imprimis Pharmaceuticals Center for Drug Evaluation and Research Finished Pharmaceuticals/Misbranded Not Issued *
12/21/2017 Centro Mas Salud Dr. Gualberto Rabell-Fernandez Florida District Office Mammography Quality Standards Not Issued *
12/21/2017 Continental Manufacturing Chemist, Inc. Detroit District Office CGMP/Drug Products/Adulterated Not Issued *
12/21/2017 Optimum Bioenergy International Corp. San Francisco District Office CGMP/Dietary Supplement/Adulterated/Misbranded Not Issued *
12/20/2017 Schrofner Cosmetics Gmbh Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
12/19/2017 Neilsen Seafood Cincinnati District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
12/19/2017 Delta Laboratories Pty Ltd Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
12/19/2017 C. O. Truxton Inc. New Jersey District Office CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *
12/19/2017 Maine Natural Health, Inc. New York District Office CGMP/Dietary Supplement/Adulterated/Misbranded Not Issued *
12/18/2017 Fresenius Kabi Oncology Limited (Baddi) Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
12/18/2017 Deserving Health International Corp Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
12/18/2017 Wuhan Chinese Moxibustion Technology Dev. Co., Ltd. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
12/18/2017 Prosana Distribuciones SA de CV Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug/Misbranded Not Issued *
12/15/2017 Gold Star Smoked Fish Corp. New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
12/14/2017 BrainAlert, LLC Seattle District Office CGMP/Dietary Supplement/Adulterated/Misbranded 04/27/2018
12/14/2017 Eden’s Answers Inc. and Sprigs Life Inc. Cincinnati District Office Unapproved New Drugs/Misbranded Not Issued *
12/13/2017 GnuPharma Corp. Dallas District Office CGMP/Dietary Supplement/Adulterated/Misbranded Not Issued *
12/13/2017 Dynamic Technical Formulations Atlanta District Office CGMP/Dietary Supplement/Adulterated/Misbranded Not Issued *
12/13/2017 AN Co. Ltd. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
12/13/2017 Amaros Co., Ltd Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
12/13/2017 Buffalo Pharmacies Inc. dba Swan Prescription Center New Jersey District Office Compounding Pharmacy/Adulterated Drug Products Not Issued *
12/11/2017 Arco Globus Trading LLC Center for Drug Evaluation and Research Unapproved New Drugs/Misbranded Not Issued *
12/08/2017 K & S Food Center LLC New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
12/07/2017 Health-Chem Diagnostics, LLC Florida District Office Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Not Issued *
12/05/2017 A.I.G Technologies, Inc. Dallas District Office New Drug/Misbranded Not Issued *
12/05/2017 Aphena Pharma Solutions-Tennessee, LLC Center for Drug Evaluation and Research Failure to Comply with Drug Listing Requirements/Misbranded 01/31/2018
12/05/2017 Shanwei Honghui Daily Appliance Co., Ltd. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
12/05/2017 Hieber's Pharmacy New Jersey District Office Compounding Pharmacy/Adulterated Drug Products Not Issued *
12/05/2017 Seindni Co., Ltd. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
12/04/2017 Fresenius Kabi Oncology Ltd Center for Drug Evaluation and Research CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Not Issued *
12/01/2017 Bedessee Imports, Inc New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
11/30/2017 Wellness Resources, Inc. Minneapolis District Office New Drug/Labeling/Misbranded Not Issued *
11/30/2017 Crosbys Drugs Inc Detroit District Office Compounding Pharmacy/Adulterated Drug Products Not Issued *
11/30/2017 TruVision Health LLC Denver District Office CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug Not Issued *
11/29/2017 BBCOS srl Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
11/28/2017 RC Outsourcing LLC Detroit District Office Compounding Pharmacy/Adulterated Drug Products Not Issued *
11/28/2017 Fagron Compounding Services LLC dba Fagron Sterile Services Detroit District Office Compounding Pharmacy/Adulterated Drug Products Not Issued *
11/22/2017 First Choice E Trading Corp. New York District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
11/20/2017 Dae Young Foods Co., Ltd. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
11/17/2017 Hangzhou Facecare Cosmetics Co., Ltd. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
11/17/2017 Nova Distributors, LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
11/17/2017 Rushing Waters Fisheries, LLC Minneapolis District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
11/16/2017 U.L. Manufacturing Company Ltd. Center for Food Safety and Applied Nutrition Acidified Foods/Emergency Permit Control/Adulterated Not Issued *
11/16/2017 Hand Biomechanics Lab Inc Los Angeles District Office Medical Device Reporting/Misbranded Not Issued *
11/16/2017 Naturefield Company Limited Center for Food Safety and Applied Nutrition Juice/HACCP/Adulterated Not Issued *
11/15/2017 Hilgenkamp Farm Inc Kansas City District Office Food/Edible Tissue/Drug Residue/Adulterated Not Issued *

Page Last Updated: 09/23/2018
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