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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2014 Warning Letters

 
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Letter Issue Date Company Name Issuing Office Subject Close Out Date
03/14/2014 Pattanam D. Srinivasan, MD Center for Devices and Radiological Health Sponsor-Investigator Not Issued *
03/13/2014 Libi Labs, Inc. Florida District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
03/12/2014 Savar Food Products, Inc. New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 12/17/2014
03/11/2014 Colorado Histo-Prep Center for Drug Evaluation and Research Good Laboratory Practice (GLP) Not Issued *
03/11/2014 Teleflex Medical Chicago District Office CGMP/QSR/Medical Devices/Adulterated 09/14/2015
03/11/2014 Royal Foods Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
03/09/2014 Jieying Laboratory Inc Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
03/07/2014 Deseo Rebajar San Juan District Office Unapproved and Misbranded New Drugs 07/21/2015
03/07/2014 Martin, Marlin Detroit District Office Illegal Drug Residue 10/15/2014
03/07/2014 Russian Products, Inc. New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
03/07/2014 Pentec Health Philadelphia District Office Drug Product/Adulterated Not Issued *
03/07/2014 Hospira, Inc. Atlanta District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
03/06/2014 Golden Crown Bakery, Inc. dba Panzanella Bread Company Seattle District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
03/06/2014 La Tienda, Inc. Baltimore District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 06/18/2015
03/06/2014 Smruthi Organics Limited Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated/HPLC Not Issued *
03/06/2014 Han Sung Sikpoom Trading Co. New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 04/23/2015
03/06/2014 Diamond B Dairy Seattle District Office Illegal Drug Residue Not Issued *
03/06/2014 Marfish, Inc. Florida District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
03/06/2014 Hong Lee Trading Inc New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 04/23/2015
03/06/2014 Britto Seafoods Exports Pvt. Ltd. Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
03/04/2014 Ocean Queen USA, Inc., dba IMP Foods, Inc. San Francisco District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
03/03/2014 Erickson Dairy LLC Minneapolis District Office Illegal Drug Residue 04/25/2014
02/28/2014 Total Pharmacy Services, Inc. New Orleans District Office CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
02/28/2014 Wilton Black New England District Office Illegal Drug Residue Not Issued *
02/28/2014 Richard Wolf Medical Instruments Corp. Chicago District Office CGMP/QSR/Medical Devices/Adulterated 06/04/2015
02/28/2014 Village Fertility Pharmacy, Inc. New England District Office CGMP/Drugs/Prepared, Packed or Held Under Insanitary Conditions/Adulterated 07/25/2016
02/27/2014 Canton Laboratories Pvt. Ltd. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
02/27/2014 Cooper Vision Caribbean Corp. San Juan District Office CGMP/QSR/Medical Devices/Adulterated 10/20/2014
02/26/2014 Neomedix Corp Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) 05/21/2014
02/25/2014 Ontario Ranch Holsteins Los Angeles District Office Illegal Drug Residue Not Issued *
02/25/2014 Canadian Feedyard, LLLP Dallas District Office Illegal Drug Residue 03/17/2015
02/21/2014 Wedgewood Village Pharmacy, Inc. New Jersey District Office CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *
02/21/2014 Zimmermann, Ralf C. Center for Drug Evaluation and Research Clinical Investigator Not Issued *
02/21/2014 Apple Valley Orchards, LLC. New Orleans District Office Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 01/23/2015
02/20/2014 Falls View Farm New York District Office Illegal Drug Residue Not Issued *
02/19/2014 Pallimed Solutions, Inc. New England District Office CGMP/Drugs/Prepared, Packed or Held Under Insanitary Conditions/Adulterated Not Issued *
02/18/2014 Bridgewater Dairy LLC. Cincinnati District Office Illegal Drug Residue Not Issued *
02/18/2014 Lowlite Investments, Inc. D/B/A Olympia Pharmacy Florida District Office CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
02/14/2014 Nora Apothecary Pharmacy Detroit District Office CGMP/Finished Pharmaceuticals/Adulterated/Misbranded 08/10/2017
02/14/2014 17 Merrill Drive LLC New England District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
02/14/2014 Newberry Feed & Farm, Inc. Atlanta District Office CGMP/Medicated Feeds/Adulterated Not Issued *
02/12/2014 Reyskens Dairy Llc Cincinnati District Office Illegal Drug Residue Not Issued *
02/12/2014 Bluegrass Dairy and Food Inc Cincinnati District Office Food/Prepared Packed or Held Under Insanitary Conditions/Adulterated 05/05/2015
02/12/2014 Smoke Shop Plus Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 09/04/2014
02/11/2014 Maximus Niterider International Group, Inc. Los Angeles District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated 03/25/2014
02/11/2014 Hometown Veterinary Care, P.C. New England District Office Illegal Drug Residue Not Issued *
02/11/2014 www.smokecitymichigan.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 09/25/2014
02/07/2014 Advanced Interventional Pain Ctr IRB Center for Devices and Radiological Health Institutional Review Board (IRB) Not Issued *
02/06/2014 Schafer Fisheries Chicago District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 06/22/2016
02/06/2014 Usv Limited Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *

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