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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
June 06, 2014 Lee and Company Dallas District Office CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
June 06, 2014 www.200cheapcigarettes.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
June 06, 2014 Carefusion 2200 Inc Chicago District Office CGMP/QSR/Medical Devices/Adulterated September 17, 2015
June 05, 2014 Nutrishop New Jersey District Office Unapproved New Drug/Misbranded Not Issued *
June 05, 2014 Rod McNeal Dairy Dallas District Office Illegal Drug Residue June 29, 2015
June 05, 2014 www.buy-cheapcigarettes.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
June 05, 2014 www.smokerdirect.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
June 04, 2014 Owen Mumford USA, Inc. Atlanta District Office Medical Device Reporting/Misbranded Not Issued *
June 04, 2014 Enhancement Medical, LLC Minneapolis District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
June 04, 2014 Polonica Inc. New Jersey District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions August 24, 2015
June 02, 2014 American Antibiotics, Inc. Center for Drug Evaluation and Research Generic Drug User Fee Amendments of 2012 (GDUFA) July 23, 2014
June 02, 2014 HeartWare Inc Florida District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
June 02, 2014 Accelerated Freeze Drying Co. Ltd. Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
June 02, 2014 Antibioticos, S.A. Center for Drug Evaluation and Research Generic Drug User Fee Amendments of 2012 (GDUFA) Not Issued *
May 30, 2014 Roundman's Smokehouse San Francisco District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
May 30, 2014 Neurolumen LLC Dallas District Office CGMP/QSR/Medical Devices/Adulterated November 30, 2015
May 30, 2014 www.duty-free-goods.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
May 29, 2014 www.cigaretteshouse.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded November 26, 2014
May 29, 2014 Luce Dairy Farm New York District Office Illegal Drug Residue Not Issued *
May 29, 2014 LSG Sky Chefs, Inc. Seattle District Office Airline Catering Facility/Labeling/Misbranded Not Issued *
May 29, 2014 Bhelliom Enterprises Corp Florida District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
May 29, 2014 www.cigarette-brands.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
May 27, 2014 Oakdell Pharmacy, Inc Dallas District Office CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *
May 25, 2014 Precision Needle Manufacturing, Inc. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
May 22, 2014 Aesthetics Systems Usa Inc Center for Devices and Radiological Health Promotion and Advertising/Misleading/Misbranded Not Issued *
May 22, 2014 Steris Isomedix Services Chicago District Office CGMP/QSR/Medical Devices/Adulterated November 24, 2015
May 22, 2014 Shawn Bender New York District Office Illegal Drug Residue Not Issued *
May 22, 2014 Gourmail, Inc. dba Jyoti Natural Foods Philadelphia District Office CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated November 18, 2014
May 21, 2014 Life Force of Tampa, LLC Florida District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
May 21, 2014 The Utopia Group LLC Cincinnati District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
May 21, 2014 Staar Surgical Co. Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
May 21, 2014 A.R.C. LASER GMBH Center for Devices and Radiological Health Medical Device Reporting/Misbranded Not Issued *
May 21, 2014 CJ Dairy Farm New York District Office Illegal Drug Residue Not Issued *
May 20, 2014 BEK Catering, LLC dba Floppers Foods New Orleans District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
May 20, 2014 Bliss Dairy, LLC Denver District Office Illegal Drug Residue May 20, 2014
May 20, 2014 Hemcon Medical Technologies, Inc. Seattle District Office Device/Lacks Premarket Approval Notification/Adulterated Not Issued *
May 16, 2014 Jack Hall Farm Cincinnati District Office Illegal Drug Residue Not Issued *
May 16, 2014 R&D Engineering Of Earlham Inc Kansas City District Office Medical Device/CGMP/Adulterated Not Issued *
May 15, 2014 AMK Food Export (Pvt) Ltd Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated, Low Acid Canned Food Regulation/Adulterated November 18, 2014
May 15, 2014 Southeast Asian Packaging and Canning Limited. Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
May 14, 2014 SSE Manufacturing, Inc Dallas District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
May 13, 2014 Fiber Foods, Incorporated Baltimore District Office Food Labeling/Adulterated/Misbranded January 26, 2015
May 13, 2014 Louisa Food Products Inc Kansas City District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions February 23, 2015
May 13, 2014 Cardiac Assist, Inc Philadelphia District Office Medical Device Reporting/Misbranded November 25, 2014
May 13, 2014 Maharaja Foods Importers Inc. New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
May 12, 2014 Led Dental Inc Center for Devices and Radiological Health Promotion and Advertising/Misleading/Misbranded December 21, 2015
May 12, 2014 Veinwave Ltd Center for Devices and Radiological Health Promotion and Advertising/Misleading/Misbranded Not Issued *
May 09, 2014 Nature's Pharmacy & Compounding Center Atlanta District Office CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
May 09, 2014 Jade & Pearl, Inc. Florida District Office Medical Device Reporting/Premarket Approval/Misbranded Not Issued *
May 08, 2014 Advanced Renal Technologies Inc Seattle District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded March 02, 2016

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