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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

2013 Warning Letters

Letter Issue Date Company Name Issuing Office Subject Close Out Date
May 02, 2013 WEBER MEDICAL GMBH Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated Not Issued *
May 01, 2013 Seven Seas Smoke House and Catering Services, Inc. Los Angeles District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
May 01, 2013 Riverpoint Medical, LLC Seattle District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
May 01, 2013 Pacific Harvest Seafoods, Inc. San Francisco District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
May 01, 2013 GRI Medical & Electronic Technology Co., Ltd. Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated Not Issued *
May 01, 2013 Dale Schmitmeyer Farm Cincinnati District Office Illegal Drug Residue Not Issued *
April 30, 2013 Biocompatibles Inc. New England District Office CGMP/QSR/Medical Devices/Adulterated April 15, 2014
April 30, 2013 Electromedical Products International, Inc Dallas District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
April 30, 2013 http://www.cigarettes-info.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded July 31, 2013
April 30, 2013 support@cigarettes-shop.net Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
April 30, 2013 www.AdilacCoffee.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded June 11, 2013
April 26, 2013 V-SAB Medical Labs, Inc. Atlanta District Office CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *
April 26, 2013 ACell, Inc Baltimore District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
April 26, 2013 Pristine Bay LLC dba Vianda Cincinnati District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
April 26, 2013 Zeinstra Farms, LLC Detroit District Office Illegal Drug Residue February 04, 2014
April 26, 2013 Sirob Imports, Inc. New York District Office Acidified Foods/Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
April 25, 2013 CMI Cosmetic Manufacturers Inc. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
April 25, 2013 Nouritress Hair Products, LLC Atlanta District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
April 25, 2013 CooperSurgical, Inc. D.B.A. Lone Star Medical Products Dallas District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Not Issued *
April 25, 2013 Shippert Medical Technologies Denver District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *



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