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

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