• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

  • Print
  • Share
  • E-mail

2013 Warning Letters

 
-
Letter Issue Date Company Name Issuing Office Subject Close Out Date
05/09/2013 Hospira Inc. Chicago District Office CGMP/QSR/Medical Devices/Adulterated 10/12/2016
05/08/2013 LISA Laser Products OHG Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded 04/01/2015
05/08/2013 Entrenet Nutritionals, Inc. Philadelphia District Office Unapproved and Misbranded New Drugs 12/31/2014
05/07/2013 Standard Textile Co Inc Cincinnati District Office Premarket Approval/Misbranded/Adulterated 06/24/2013
05/07/2013 The Standing Company Detroit District Office CGMP/QSR/Medical Devices/Adulterated 11/24/2015
05/06/2013 Rubimed AG Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
05/06/2013 Invatec S.p.A. Center for Devices and Radiological Health Quality System Regulation/Adulterated/Medical Device Reporting/Misbranded 02/02/2015
05/06/2013 Boehringer Ingelheim Pharma GMBH & Co Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated 06/05/2014
05/03/2013 SmartPractice Center for Biologics Evaluation and Research False & Misleading Claims/Misbranded Not Issued *
05/02/2013 American Natural Products Inc Florida District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
05/02/2013 Earthborn Products, Inc. Los Angeles District Office New Drug/Labeling/Misbranded Not Issued *
05/02/2013 WEBER MEDICAL GMBH Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated Not Issued *
05/02/2013 Alternative Health Supplements Detroit District Office Unapproved and Misbranded New Drugs Not Issued *
05/01/2013 Seven Seas Smoke House and Catering Services, Inc. Los Angeles District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
05/01/2013 GRI Medical & Electronic Technology Co., Ltd. Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated 10/09/2014
05/01/2013 Dale Schmitmeyer Farm Cincinnati District Office Illegal Drug Residue Not Issued *
05/01/2013 Pacific Harvest Seafoods, Inc. San Francisco District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
05/01/2013 Ace Medical Corp., Ltd. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
05/01/2013 Riverpoint Medical, LLC Seattle District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
04/30/2013 Electromedical Products International, Inc Dallas District Office CGMP/QSR/Medical Devices/Adulterated 09/18/2014
04/30/2013 http://www.cigarettes-info.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 07/31/2013
04/30/2013 Biocompatibles Inc. New England District Office CGMP/QSR/Medical Devices/Adulterated 04/15/2014
04/30/2013 support@cigarettes-shop.net Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
04/30/2013 www.AdilacCoffee.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 06/11/2013
04/26/2013 Sirob Imports, Inc. New York District Office Acidified Foods/Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
04/26/2013 Zeinstra Farms, LLC Detroit District Office Illegal Drug Residue 02/04/2014
04/26/2013 Pristine Bay LLC dba Vianda Cincinnati District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
04/26/2013 V-SAB Medical Labs, Inc. Atlanta District Office CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *
04/26/2013 ACell, Inc Baltimore District Office CGMP/QSR/Medical Devices/Adulterated 06/01/2016
04/25/2013 Quantum Herbal Products New York District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
04/25/2013 CooperSurgical, Inc. D.B.A. Lone Star Medical Products Dallas District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated 09/12/2017
04/25/2013 CMI Cosmetic Manufacturers Inc. Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
04/25/2013 Shippert Medical Technologies Denver District Office CGMP/QSR/Medical Devices/Adulterated 08/20/2014
04/25/2013 Nouritress Hair Products, LLC Atlanta District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
04/24/2013 Olympia Womens Health Seattle District Office Deviations from CFR Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) Not Issued *
04/24/2013 Europharma Co., Inc. Minneapolis District Office New Drug/Labeling/False & Misleading Claims Not Issued *
04/24/2013 Glucorell, Inc. / Anafit, Inc. Florida District Office Unapproved and Misbranded New Drugs Not Issued *
04/23/2013 Glottal Enterprises Inc. New York District Office Medical Device Reporting/Misbranded 03/10/2015
04/23/2013 www.cheapcigarette4you.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 06/12/2013
04/23/2013 Care Diagnostica GmbH Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated Not Issued *
04/23/2013 A & M Bakery, Inc. Baltimore District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions 01/30/2015
04/19/2013 Kato Suisan Co. Ltd. Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 09/13/2013
04/19/2013 Kosher Foods Unlimited, Inc. dba got kosher ? Los Angeles District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 04/29/2015
04/19/2013 MEDICAMAT S.A. Center for Devices and Radiological Health Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) 08/19/2014
04/19/2013 Sushi USA Inc. Baltimore District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
04/19/2013 Natus Europe GmbH Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded 01/13/2014
04/18/2013 Freskeeto Frozen Foods Inc New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 10/07/2013
04/18/2013 COVI S.A.S Center for Food Safety and Applied Nutrition Low Acid Canned Food Regulation/Adulterated 05/07/2013
04/18/2013 Biofournil Of America Inc. Seattle District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
04/18/2013 Blackstar Fish Co Inc Cincinnati District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *

-