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

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