Inspections, Compliance, Enforcement, and Criminal Investigations

2015 Warning Letters

Letter Issue Date Company Name Issuing Office Subject Close Out Date
02/04/2015 Verichem Laboratories, Inc. New England District Office CGMP/QSR/Medical Devices/Adulterated 11/07/2016
02/03/2015 Dutchman's Bakeshop, LLC Baltimore District Office CGMP Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated   Not Issued *
02/03/2015 Perry Drug Inc. Kansas City District Office Unapproved New Drug/Compounding/Misbranding/Adulterated 11/18/2016
02/03/2015 West Hope Dairy, LLC Baltimore District Office Illegal Drug Residue 02/12/2015
02/02/2015 Barrington Dairy Farm Florida District Office Illegal Drug Residue Not Issued *
01/30/2015 Zunker, Andrew G. Minneapolis District Office Illegal Drug Residue 05/19/2015
01/30/2015 Apotex Research Private Limited Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated 12/20/2016
01/30/2015 Schneider Dairy Detroit District Office Illegal Drug Residue 03/05/2015
01/30/2015 Cowles Farms, LLC New York District Office Illegal Drug Residue Not Issued *
01/30/2015 Oak Hill Farm Philadelphia District Office Illegal Drug Residue 02/01/2016
01/30/2015 Daniel Nickerson New York District Office Illegal Drug Residue Not Issued *
01/29/2015 F.P. Rubinstein Y Cia SRL Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
01/29/2015 Somatex Medical Technologies GmbH Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated 11/13/2015
01/29/2015 Bezon Farms Inc New York District Office Illegal Drug Residue Not Issued *
01/27/2015 Oregon Compounding Centers, Inc. dba Creative Compounds Seattle District Office CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *
01/26/2015 Lussier Dairy, Inc. Florida District Office Illegal Drug Residue Not Issued *
01/23/2015 Sudan Vet Services Dallas District Office Illegal Drug Residue Not Issued *
01/23/2015 GVS Filter Technology UK Ltd Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated 02/14/2017
01/21/2015 Nanosphere, Inc. Chicago District Office CGMP/QSR/Medical Devices/Adulterated 06/30/2017
01/21/2015 Pristine Nutraceuticals, LLC. Florida District Office New Drug/Labeling/Misbranded Not Issued *
01/21/2015 Cantrell Drug Company Dallas District Office CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
01/21/2015 Pearson, Eric J. Philadelphia District Office Illegal Drug Residue 12/07/2015
01/21/2015 DZH Import & Export Inc. New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
01/21/2015 Fragrance Manufacturing, Inc. D/b/a FMI Philadelphia District Office CGMP/Dietary Supplement/Adulterated/Misbranded 10/26/2016
01/20/2015 Stonegate Farms Dallas District Office Illegal Drug Residue Not Issued *
01/20/2015 Chaga Mountain, Inc. New England District Office Unapproved New Drugs/Misbranded 09/19/2016
01/16/2015 Porky's Gourmet Foods, Inc. New Orleans District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
01/16/2015 usa-cigs.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
01/15/2015 Criticare Systems (Malaysia) Sdn. Bhd. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
01/14/2015 Balmer Brothers Philadelphia District Office Illegal Drug Residue 01/04/2016
01/13/2015 Bluefin Seafoods Corporation Cincinnati District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 10/27/2015
01/13/2015 Lanter Distributing LLC Atlanta District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
01/13/2015 Carrington Center for Food Safety and Applied Nutrition Unapproved New Drugs/Misbranded Not Issued *
01/13/2015 Sunny Boys Dairy Denver District Office Illegal Drug Residue 01/13/2016
01/12/2015 Combo AG Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
01/12/2015 Kaiya Medical (dba Care Medical - Foshan) Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
01/12/2015 Conkin Surgical Instruments Ltd. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated 01/15/2016
01/09/2015 Spurlock Farms Dallas District Office Illegal Drug Residue Not Issued *
01/09/2015 Medical Supply Liquidators Llc Kansas City District Office New Drug/Labeling/Misbranded Not Issued *
01/09/2015 TreyMed, Inc. Minneapolis District Office CGMP/QSR/Medical Devices/Adulterated 08/21/2017
01/09/2015 Derma Pen, LLC Denver District Office Premarket Approval/Misbranded/Adulterated Not Issued *
01/09/2015 Micro Labs Limited Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
01/09/2015 SDP Marketing and Distribution, Inc. Los Angeles District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
01/08/2015 Caliber Imaging & Diagnostics, Inc. Center for Devices and Radiological Health Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) 11/06/2018
01/08/2015 Collagen Matrix Inc Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
01/08/2015 Complete H2O Minerals Atlanta District Office CGMP/Dietary Supplement/Adulterated/Misbranded Not Issued *
01/08/2015 Aloe Man, Inc. (The) Atlanta District Office Unapproved New Drugs/Misbranded Not Issued *
01/07/2015 Smucker, Samuel Philadelphia District Office Illegal Drug Residue 12/07/2015
01/07/2015 NYSW Beverage Brands New York District Office CGMP/Dietary Supplement/Adulterated/Misbranded 10/31/2017
01/07/2015 The Pipe Shop Edinburgh Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *

Page Last Updated: 12/13/2018
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