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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2013 Warning Letters

 
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Letter Issue Date Company Name Issuing Office Subject Close Out Date
May 08, 2013 LISA Laser Products OHG Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded April 01, 2015
May 08, 2013 Entrenet Nutritionals, Inc. Philadelphia District Office Unapproved and Misbranded New Drugs December 31, 2014
May 07, 2013 Standard Textile Co Inc Cincinnati District Office Premarket Approval/Misbranded/Adulterated June 24, 2013
May 07, 2013 The Standing Company Detroit District Office CGMP/QSR/Medical Devices/Adulterated November 24, 2015
May 06, 2013 Invatec S.p.A. Center for Devices and Radiological Health Quality System Regulation/Adulterated/Medical Device Reporting/Misbranded February 02, 2015
May 06, 2013 Rubimed AG Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
May 06, 2013 Boehringer Ingelheim Pharma GMBH & Co Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated June 05, 2014
May 03, 2013 SmartPractice Center for Biologics Evaluation and Research False & Misleading Claims/Misbranded Not Issued *
May 02, 2013 WEBER MEDICAL GMBH Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated Not Issued *
May 02, 2013 American Natural Products Inc Florida District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
May 02, 2013 Earthborn Products, Inc. Los Angeles District Office New Drug/Labeling/Misbranded Not Issued *
May 02, 2013 Alternative Health Supplements Detroit District Office Unapproved and Misbranded New Drugs 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 Dale Schmitmeyer Farm Cincinnati District Office Illegal Drug Residue Not Issued *
May 01, 2013 GRI Medical & Electronic Technology Co., Ltd. Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated October 09, 2014
May 01, 2013 Pacific Harvest Seafoods, Inc. San Francisco District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
May 01, 2013 Ace Medical Corp., Ltd. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
May 01, 2013 Riverpoint Medical, LLC Seattle District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
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 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 September 18, 2014
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 www.AdilacCoffee.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded June 11, 2013
April 26, 2013 Sirob Imports, Inc. New York District Office Acidified Foods/Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 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 ACell, Inc Baltimore District Office CGMP/QSR/Medical Devices/Adulterated June 01, 2016
April 26, 2013 V-SAB Medical Labs, Inc. Atlanta District Office CGMP/Finished Pharmaceuticals/Adulterated/Misbranded 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 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 Shippert Medical Technologies Denver District Office CGMP/QSR/Medical Devices/Adulterated August 20, 2014
April 25, 2013 Quantum Herbal Products New York District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
April 24, 2013 Europharma Co., Inc. Minneapolis District Office New Drug/Labeling/False & Misleading Claims Not Issued *
April 24, 2013 Olympia Womens Health Seattle District Office Deviations from CFR Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) Not Issued *
April 24, 2013 Glucorell, Inc. / Anafit, Inc. Florida District Office Unapproved and Misbranded New Drugs Not Issued *
April 23, 2013 Care Diagnostica GmbH Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated Not Issued *
April 23, 2013 A & M Bakery, Inc. Baltimore District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions January 30, 2015
April 23, 2013 www.cheapcigarette4you.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded June 12, 2013
April 23, 2013 Glottal Enterprises Inc. New York District Office Medical Device Reporting/Misbranded March 10, 2015
April 19, 2013 Kato Suisan Co. Ltd. Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
April 19, 2013 Natus Europe GmbH Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded January 13, 2014
April 19, 2013 Kosher Foods Unlimited, Inc. dba got kosher ? Los Angeles District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions April 29, 2015
April 19, 2013 MEDICAMAT S.A. Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) August 19, 2014
April 19, 2013 Sushi USA Inc. Baltimore District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
April 18, 2013 Aurora Optics Company Inc New York District Office Medical Device Reporting/Misbranded Not Issued *
April 18, 2013 Biofournil Of America Inc. Seattle District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
April 18, 2013 COVI S.A.S Center for Food Safety and Applied Nutrition Low Acid Canned Food Regulation/Adulterated May 07, 2013
April 18, 2013 Blackstar Fish Co Inc Cincinnati District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
April 18, 2013 Freskeeto Frozen Foods Inc New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions October 07, 2013

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