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

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