Inspections, Compliance, Enforcement, and Criminal Investigations

2017 Warning Letters

Letter Issue Date Company Name Issuing Office Subject Close Out Date
04/17/2017 Aie Pharmaceuticals Inc Los Angeles District Office Unapproved New Drugs/Misbranded Not Issued *
04/17/2017 Sunstone, Inc. Denver District Office Unapproved New Drugs/Misbranded Not Issued *
04/17/2017 DoctorVicks.com New York District Office Unapproved New Drugs/Misbranded 02/02/2018
04/17/2017 Oxygen Health Systems, LLC Chicago District Office Unapproved New Drugs/Misbranded Not Issued *
04/17/2017 BioStar Technology International, LLC Los Angeles District Office Unapproved New Drugs/Misbranded 12/14/2018
04/17/2017 Hawk Dok Natural Salve, LLC Los Angeles District Office Unapproved New Drugs/Misbranded Not Issued *
04/17/2017 Healing Within Products & Services, Inc. San Francisco District Office Unapproved New Drugs/Misbranded Not Issued *
04/17/2017 Nature's Treasures Los Angeles District Office Unapproved New Drugs/Misbranded Not Issued *
04/14/2017 Caudill Seed & Warehouse Inc Cincinnati District Office Unapproved New Drugs/Misbranded Not Issued *
04/14/2017 Genetic Edge Compounds LLC Dallas District Office CGMP/Dietary Supplement/Adulterated/Misbranded 06/05/2018
04/13/2017 Divi's Laboratories Ltd. (Unit II) Center for Drug Evaluation and Research CGMP/Active Pharmaceutical Ingredient (API)/Adulterated/Refused Inspection 11/07/2017
04/12/2017 Abbott (St Jude Medical Inc.) Center for Devices and Radiological Health CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Not Issued *
04/10/2017 Quality Fisheries dba The Niota Fish Market Chicago District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
04/10/2017 Safe Harbour Seafood, Inc New Orleans District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
04/07/2017 Arnold Professional Pharmacy Baltimore District Office Compounding Pharmacy/Adulterated Drug Products Not Issued *
04/06/2017 Entellus Medical Center for Devices and Radiological Health Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Not Issued *
04/06/2017 Bebe Toys Manufactory Ltd. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
04/05/2017 Teva Pharmaceutical and Chemical (Hangzhou) Co. Ltd. Center for Drug Evaluation and Research CGMP/Active Pharmaceutical Ingredient (API)/Adulterated 04/25/2018
04/05/2017 Jus Bar LLC New York District Office Unapproved New Drugs/Misbranded Not Issued *
04/04/2017 SI Marketing Inc. San Francisco District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
04/04/2017 Granja Cintron San Juan District Office PHS Act/Shell Egg Regulation/Adulterated Not Issued *
04/04/2017 Abbott's Compounding Pharmacy, Inc. San Francisco District Office Compounding Pharmacy/Adulterated Drug Products Not Issued *
04/04/2017 American Specialty Pharmacy Dallas District Office Drug Product/Adulterated 11/07/2018
04/03/2017 Professional Arts Pharmacy Baltimore District Office Drug Product/Adulterated
04/03/2017 Mylan Laboratories Limited, (Nashik FDF) Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated 07/18/2018
04/03/2017 Santos Agency Inc. San Francisco District Office CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated 04/02/2018
03/29/2017 Targeted Medical Pharma, Inc. dba Physician Therapeutics Center for Drug Evaluation and Research Sponsor/Investrigator Not Issued *
03/29/2017 Enclara Pharmacia Inc Philadelphia District Office Drug Product/Adulterated 01/19/2018
03/29/2017 Hebei Pukang Medical Instruments Co., Ltd. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
03/29/2017 Well Care Compounding Pharmacy San Francisco District Office Compounding Pharmacy/Adulterated Drug Products Not Issued *
03/28/2017 Ranier's Compounding Laboratory Philadelphia District Office Compounding Pharmacy/Adulterated Drug Products Not Issued *
03/27/2017 Indoco Remedies Limited Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
03/24/2017 KC Innovations, Inc Kansas City District Office Acidified Foods/Prepared Packed or Held Under Insanitary Conditions Not Issued *
03/24/2017 Sanapac Co., Inc. Philadelphia District Office CGMP/Dietary Supplement/Adulterated/Misbranded Not Issued *
03/23/2017 X12 Co., LTD. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
03/23/2017 Daesang America Inc New Jersey District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
03/22/2017 Iacofano's Group LLC Atlanta District Office Airline Catering Facility/Labeling/Misbranded Not Issued *
03/22/2017 Trone Health Services, Inc. Seattle District Office Compounding Pharmacy/Adulterated Drug Products Not Issued *
03/22/2017 H & W Farms LLC Detroit District Office Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
03/21/2017 Ba Hai Company Limited Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 11/03/2017
03/20/2017 ImprimisRx CA, Inc., dba ImprimisRx Los Angeles District Office Compounding Pharmacy/Adulterated Drug Products Not Issued *
03/20/2017 Northwest Frozen, LLC dba Banzai Sushi (Banzai) Seattle District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
03/20/2017 Merrill D. Benson, M.D. Center for Drug Evaluation and Research Sponsor/Investigator Not Issued *
03/20/2017 Vacunda & Design San Juan District Office New Drug/Misbranded Not Issued *
03/17/2017 Merges, Brian J Kansas City District Office Illegal Drug Residue Animal Tissue/Adulterated 04/05/2018
03/16/2017 Day Fish Co Inc Minneapolis District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
03/16/2017 Opto-Pharm Pte Ltd. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug Not Issued *
03/16/2017 Nobel Bakery, Inc. Los Angeles District Office CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated Not Issued *
03/16/2017 DSE Healthcare Solutions, LLC New Jersey District Office CGMP/Dietary Supplement/Adulterated/Misbranded Not Issued *
03/15/2017 MIYAQUIL SA Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *

Page Last Updated: 04/23/2019
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