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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
06/06/2014 www.200cheapcigarettes.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
06/06/2014 MTI Precision Products LLC. New Jersey District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
06/06/2014 Carefusion 2200 Inc Chicago District Office CGMP/QSR/Medical Devices/Adulterated 09/17/2015
06/05/2014 Nutrishop New Jersey District Office Unapproved New Drug/Misbranded Not Issued *
06/05/2014 www.buy-cheapcigarettes.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
06/05/2014 www.smokerdirect.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
06/05/2014 Rod McNeal Dairy Dallas District Office Illegal Drug Residue 06/29/2015
06/04/2014 Owen Mumford USA, Inc. Atlanta District Office Medical Device Reporting/Misbranded Not Issued *
06/04/2014 Polonica Inc. New Jersey District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 08/24/2015
06/04/2014 Enhancement Medical, LLC Minneapolis District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
06/02/2014 HeartWare Inc Florida District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
06/02/2014 American Antibiotics, Inc. Center for Drug Evaluation and Research Generic Drug User Fee Amendments of 2012 (GDUFA) 07/23/2014
06/02/2014 Accelerated Freeze Drying Co. Ltd. Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
06/02/2014 Antibioticos, S.A. Center for Drug Evaluation and Research Generic Drug User Fee Amendments of 2012 (GDUFA) Not Issued *
05/30/2014 www.duty-free-goods.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
05/30/2014 Neurolumen LLC Dallas District Office CGMP/QSR/Medical Devices/Adulterated 11/30/2015
05/30/2014 Roundman's Smokehouse San Francisco District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
05/29/2014 Luce Dairy Farm New York District Office Illegal Drug Residue Not Issued *
05/29/2014 www.cigaretteshouse.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 11/26/2014
05/29/2014 LSG Sky Chefs, Inc. Seattle District Office Airline Catering Facility/Labeling/Misbranded Not Issued *
05/29/2014 Bhelliom Enterprises Corp Florida District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
05/29/2014 www.cigarette-brands.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
05/27/2014 Oakdell Pharmacy, Inc Dallas District Office CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *
05/25/2014 Precision Needle Manufacturing, Inc. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
05/22/2014 Gourmail, Inc. dba Jyoti Natural Foods Philadelphia District Office CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated 11/18/2014
05/22/2014 Shawn Bender New York District Office Illegal Drug Residue Not Issued *
05/22/2014 Steris Isomedix Services Chicago District Office CGMP/QSR/Medical Devices/Adulterated 11/24/2015
05/22/2014 Aesthetics Systems Usa Inc Center for Devices and Radiological Health Promotion and Advertising/Misleading/Misbranded Not Issued *
05/21/2014 A.R.C. LASER GMBH Center for Devices and Radiological Health Medical Device Reporting/Misbranded Not Issued *
05/21/2014 Life Force of Tampa, LLC Florida District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
05/21/2014 The Utopia Group LLC Cincinnati District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
05/21/2014 Staar Surgical Co. Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
05/21/2014 CJ Dairy Farm New York District Office Illegal Drug Residue Not Issued *
05/20/2014 BEK Catering, LLC dba Floppers Foods New Orleans District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
05/20/2014 Bliss Dairy, LLC Denver District Office Illegal Drug Residue 05/20/2014
05/20/2014 Hemcon Medical Technologies, Inc. Seattle District Office Device/Lacks Premarket Approval Notification/Adulterated Not Issued *
05/16/2014 R&D Engineering Of Earlham Inc Kansas City District Office Medical Device/CGMP/Adulterated Not Issued *
05/16/2014 Jack Hall Farm Cincinnati District Office Illegal Drug Residue Not Issued *
05/15/2014 Southeast Asian Packaging and Canning Limited. Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
05/15/2014 AMK Food Export (Pvt) Ltd Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated, Low Acid Canned Food Regulation/Adulterated 11/18/2014
05/14/2014 SSE Manufacturing, Inc Dallas District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
05/13/2014 Maharaja Foods Importers Inc. New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
05/13/2014 Fiber Foods, Incorporated Baltimore District Office Food Labeling/Adulterated/Misbranded 01/26/2015
05/13/2014 Louisa Food Products Inc Kansas City District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 02/23/2015
05/13/2014 Cardiac Assist, Inc Philadelphia District Office Medical Device Reporting/Misbranded 11/25/2014
05/12/2014 Veinwave Ltd Center for Devices and Radiological Health Promotion and Advertising/Misleading/Misbranded Not Issued *
05/12/2014 Led Dental Inc Center for Devices and Radiological Health Promotion and Advertising/Misleading/Misbranded 12/21/2015
05/09/2014 Nature's Pharmacy & Compounding Center Atlanta District Office CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
05/09/2014 Jade & Pearl, Inc. Florida District Office Medical Device Reporting/Premarket Approval/Misbranded Not Issued *
05/08/2014 Nuvolase Inc. San Francisco District Office Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device Not Issued *

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