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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
07/30/2013 Trademark Co., Inc., d/b/a Golden Valley Tobacco Center for Tobacco Products Modified Risk Tobacco Products 03/10/2014
07/30/2013 Tobacco Outlet Express LLC Center for Tobacco Products Modified Risk Tobacco Products 10/07/2013
07/30/2013 CHUNGDO PHARM. CO. LTD. Center for Devices and Radiological Health Quality System Regulation for Medical Devices/Adulterated 07/21/2017
07/30/2013 RSB Tobacco Inc Center for Tobacco Products Modified Risk Tobacco Products 09/17/2013
07/30/2013 BnB Enterprise LLC Center for Tobacco Products Modified Risk Tobacco Products 07/01/2014
07/29/2013 Seafood Wholesalers, Limited Dallas District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
07/26/2013 Roth, Lonny M. Minneapolis District Office Illegal Drug Residue 03/17/2014
07/26/2013 Philemon Pty Ltd Center for Food Safety and Applied Nutrition Food Labeling/Misbranded 06/18/2014
07/26/2013 www.desismokes.com Center for Tobacco Products Modified Risk Tobacco Products 08/08/2013
07/25/2013 Brockway Hilltop Farms LLC New York District Office Illegal Drug Residue Not Issued *
07/24/2013 Northern Digital Inc. Center for Devices and Radiological Health Quality System Regulation/Adulterated/Medical Device Reporting/Misbranded 11/18/2015
07/24/2013 Sinan Dairy Farm Philadelphia District Office Illegal Drug Residue 01/16/2014
07/24/2013 Donald Potts Philadelphia District Office Illegal Drug Residue Not Issued *
07/23/2013 Natural Products Services, Inc. Los Angeles District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
07/22/2013 Goodlett Dairy Farm Cincinnati District Office Illegal Drug Residue Not Issued *
07/22/2013 N.V.E. Pharmaceuticals, Inc. New Jersey District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated 02/21/2017
07/22/2013 Ocean Beauty Seafoods, LLC Seattle District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
07/19/2013 Farmer John Egg Enterprises, Inc. San Francisco District Office PHS Act/Shell Egg Regulation/Adulterated Not Issued *
07/19/2013 ProNatural Nutrition, LLC Denver District Office CGMP for Dietary Supplements/Adulterated Not Issued *
07/18/2013 www.cigarettesforsale.org Center for Tobacco Products Modified Risk Tobacco Products 11/07/2013
07/18/2013 Wockhardt Limited Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
07/18/2013 Chesapeake Valley Water Co Kansas City District Office CGMP Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated   12/16/2014
07/17/2013 R & J Haringa Dairy Los Angeles District Office Illegal Drug Residue Not Issued *
07/16/2013 Axium Healthcare Pharmacy dba Balanced Solutions Compounding Florida District Office New Drug/Labeling/Adulterated/Misbranded Not Issued *
07/16/2013 Elmer H. Zimmerman Philadelphia District Office Illegal Drug Residue 01/21/2014
07/16/2013 Intuitive Surgical, Inc. San Francisco District Office CGMP for Medical Devices/QSR/Medical Device Reporting/Adulterated/Misbranded 04/25/2014
07/15/2013 Enhance Nutraceutical Center for Drug Evaluation and Research Unapproved New Drugs/Misbranded Not Issued *
07/15/2013 Origin BioMed Inc. Center for Drug Evaluation and Research Labeling/False & Misleading Claims/Misbranded Not Issued *
07/15/2013 Amrutam Life Care Pvt. Ltd. Center for Drug Evaluation and Research Unapproved New Drugs/Misbranded Not Issued *
07/15/2013 INS Bioscience Berhad, HLS International Sdn. Bhd., Easy Pha-max Center for Drug Evaluation and Research Unapproved New Drugs/Misbranded Not Issued *
07/15/2013 The Bagel Works Cafe Inc Kansas City District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions 07/17/2014
07/15/2013 Magni Co Dallas District Office Unapproved new drug/Misbranded Not Issued *
07/15/2013 Health Care Products New York District Office Unapproved new drug/Misbranded Not Issued *
07/15/2013 Glytain Florida District Office Unapproved new drug/Misbranded Not Issued *
07/15/2013 Neuliven Health Los Angeles District Office Unapproved new drug/Misbranded Not Issued *
07/15/2013 Nature Cast Products Florida District Office Unapproved new drug/Misbranded Not Issued *
07/15/2013 Nature's Health Supply Los Angeles District Office Unapproved new drug/Misbranded 02/13/2014
07/15/2013 www.tob-one.com Center for Drug Evaluation and Research Unapproved new drug/Misbranded Not Issued *
07/15/2013 Anastasia Marie Laboratories, Inc. Dallas District Office Unapproved new drug/Misbranded Not Issued *
07/15/2013 Pharmaterra, Inc. Seattle District Office Unapproved new drug/Misbranded Not Issued *
07/12/2013 The Muscadine Group, LLC Atlanta District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
07/12/2013 Advanced Foods New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 01/22/2014
07/11/2013 Falling Star Farm, Ltd. Cincinnati District Office Illegal Drug Residue Not Issued *
07/11/2013 Castle Cheese, Inc. Philadelphia District Office Adulterated/Misbranded Food 04/18/2014
07/11/2013 Health King Enterprise & Balanceuticals Group, Inc. Chicago District Office Unapproved new drug/Misbranded 06/24/2014
07/11/2013 Dutch Dairy Los Angeles District Office Illegal Drug Residue Not Issued *
07/11/2013 Precise Nutrition International, Inc. Los Angeles District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
07/08/2013 Grant's Smokehouse Ltd. Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 08/01/2017
07/05/2013 Hilltop Jersey Farm Dallas District Office Illegal Drug Residue Not Issued *
07/05/2013 Enraf-Nonius B.V. Center for Devices and Radiological Health Adulterated Device Not Issued *

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