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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

Letter Issue Date Company Name Issuing Office Subject Close Out Date
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   Not Issued *
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 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 *



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