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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
07/07/2014 JCB Labs LLC Kansas City District Office Compounding Pharmacy/Adulteration/Misbranding Not Issued *
07/07/2014 Trifarma S.p.A. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated 09/02/2015
07/03/2014 Hart of Texas Cattle Feeders, LLC Dallas District Office Illegal Drug Residue 06/29/2015
07/03/2014 Solace International, Inc. San Francisco District Office Unapproved New Drug/Misbranded Not Issued *
07/03/2014 Double D Dairy Detroit District Office Illegal Drug Residue 03/13/2015
07/03/2014 Walker's Food Products Co Kansas City District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 02/24/2015
07/03/2014 Easy Moon, Inc. - Ramona Egg Ranch Los Angeles District Office PHS Act/Shell Egg Regulation/Adulterated Not Issued *
07/02/2014 Sterling Heights Dairy Farm LLC Cincinnati District Office Illegal Drug Residue Not Issued *
07/02/2014 Central Soyfoods Kansas City District Office CGMP/Food/Adulterated 01/29/2015
07/02/2014 Ventlab LLC Detroit District Office CGMP/QSR/Medical Devices/Adulterated 04/28/2016
07/01/2014 Vention Medical Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated 02/25/2016
06/30/2014 I.T.S. GmbH Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
06/30/2014 Advanced MicroVas II, LLC Dallas District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
06/30/2014 Ramon Rosa San Juan District Office Unapproved New Drug/Misbranded 07/22/2015
06/30/2014 Corporacion Avicola Morovis Inc San Juan District Office PHS Act/Shell Egg Regulation/Adulterated Not Issued *
06/30/2014 Phillips Respironics, Inc. Philadelphia District Office CGMP/QSR/Medical Devices/Adulterated 03/04/2015
06/30/2014 Crossbrook Farm New York District Office Illegal Drug Residue Not Issued *
06/30/2014 Willie Schmucker New York District Office Illegal Drug Residue Not Issued *
06/27/2014 Zarbee's, Inc. Denver District Office New Drug/Labeling/Misbranded Not Issued *
06/27/2014 Zynex Medical, Inc. Denver District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
06/27/2014 Clinical Specialties Compounding Pharmacy Atlanta District Office Drug/Prepared, Packed or Held Under Insanitary Conditions/Adulterated Not Issued *
06/26/2014 Mrs Wheat's Foods Fabulous Foods, Inc. New Orleans District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
06/25/2014 Dexta Corporation San Francisco District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
06/25/2014 Conklin Dairy Sales, LLC Cincinnati District Office Illegal Drug Residue Not Issued *
06/24/2014 Unomedical s.r.o. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated 07/16/2015
06/24/2014 Sushi Den Japan Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
06/24/2014 Paul Pushlar New York District Office Illegal Drug Residue Not Issued *
06/24/2014 Albert Max Inc. dba: Vita Springs Health Los Angeles District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
06/23/2014 Veenstra Dairy #1 Seattle District Office Illegal Drug Residue Not Issued *
06/23/2014 Pharmacy Creations New Jersey District Office CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
06/23/2014 Wyldewood Cellars Inc Kansas City District Office CGMP/Dietary Supplement/Labeling/Adulterated Not Issued *
06/23/2014 God's Little Dairy New York District Office Illegal Drug Residue Not Issued *
06/20/2014 CNMC Company, Inc. New Orleans District Office CGMP/QSR/Medical Devices/PMA/Adulterated 07/24/2015
06/19/2014 Pinnacle Labs International, Inc. Los Angeles District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
06/18/2014 Conductive Technologies, Inc Philadelphia District Office CGMP/QSR/Medical Devices/Adulterated 08/19/2015
06/17/2014 Te Velde Holsteins, LLC Denver District Office Illegal Drug Residue 06/17/2015
06/16/2014 Bee-Line Farm New York District Office Illegal Drug Residue Not Issued *
06/16/2014 Apotex Pharmachem India Pvt Ltd. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated 12/20/2016
06/16/2014 Terry Pominville New York District Office Illegal Drug Residue Not Issued *
06/12/2014 Edwin Brasil Dairy San Francisco District Office Illegal Drug Residue Not Issued *
06/12/2014 ID Biomedical Corp., a subsidary of GSK Biologicals Center for Biologics Evaluation and Research CGMP/Deviations/Biologics License Application(BLA) 11/16/2015
06/12/2014 Bellisio Foods Inc Cincinnati District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 08/17/2016
06/12/2014 Spinal Elements, Inc Los Angeles District Office Premarket Approval/Misbranded/Adulterated Not Issued *
06/11/2014 SUZUKEN CO., LTD. OGUCHI CENTER Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated 09/14/2015
06/11/2014 Smith & Nephew, Inc. Florida District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
06/11/2014 MANI HANOI CO. LTD Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated 08/08/2016
06/10/2014 Tianjin Zhongan Pharmaceutical Co., Ltd. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
06/09/2014 Arno Fritz GmbH Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
06/09/2014 Newell Farms Detroit District Office Illegal Drug Residue Not Issued *
06/06/2014 Lee and Company Dallas District Office CGMP/Finished Pharmaceuticals/Adulterated Not Issued *

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