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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
October 23, 2014 Canine Care Philadelphia District Office New Animal Drug/Adulterated Not Issued *
October 23, 2014 RX South DBA RX3 Compounding Pharmacy LLC Baltimore District Office CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *
October 21, 2014 DNG Trading & Milling, LLC New York District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
October 21, 2014 Hikma Farmaceutica, (Portugal) S.A. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
October 17, 2014 Old Mill Bread Company Seattle District Office CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated Not Issued *
October 17, 2014 Golden Pride, Inc. Florida District Office Unapproved New Drugs/Misbranded Not Issued *
October 17, 2014 Vitamins Direct (USA), Inc. Florida District Office Unapproved New Drugs/Misbranded Not Issued *
October 16, 2014 Fitkin Popcorn LLC Kansas City District Office CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated Not Issued *
October 16, 2014 Alopecil Corporation, S.R.L. Center for Food Safety and Applied Nutrition CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
October 16, 2014 Vitalab Co Inc Kansas City District Office CGMP/Unapproved New Drugs/Dietary Supplements/Adulterated/Misbranding/Labeling Not Issued *
October 15, 2014 Health & Herbs Seattle District Office CGMP/Dietary Supplement/Adulterated/Therapeutic Claims Not Issued *
October 15, 2014 Sharp Global Limited Center for Drug Evaluation and Research CGMP/Active Pharmaceutical Ingredient (API)/Adulterated/Failure to Register Not Issued *
October 15, 2014 DIMA S.L. Center for Devices and Radiological Health Medical Devices/Adulterated/Quality System Regulation (QSR) Not Issued *
October 15, 2014 Citrus Fit Dallas District Office Unapproved New Drugs/Misbranded Not Issued *
October 10, 2014 IL Pastaio, Inc. San Francisco District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
October 10, 2014 Mills Dairy Farm LLC Cincinnati District Office Illegal Drug Residue Not Issued *
October 10, 2014 Biomerieux Inc Kansas City District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
October 10, 2014 Western/Scott Fetzer Company Cincinnati District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
October 10, 2014 A.M. Wholesale Fish Co. Inc. dba Syosset Seafood Co. Dallas District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
October 09, 2014 Minerva Dairy Inc Cincinnati District Office Food Labeling/Misbranded Not Issued *



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