• 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

Section Contents Menu

Enforcement Actions

2013 Warning Letters

Letter Issue Date Company Name Issuing Office Subject Close Out Date
July 19, 2013 ProNatural Nutrition, LLC Denver District Office CGMP for Dietary Supplements/Adulterated Not Issued *
July 18, 2013 Wockhardt Limited Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
July 18, 2013 www.cigarettesforsale.org Center for Tobacco Products Modified Risk Tobacco Products November 07, 2013
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 Intuitive Surgical, Inc. San Francisco District Office CGMP for Medical Devices/QSR/Medical Device Reporting/Adulterated/Misbranded Not Issued *
July 16, 2013 Elmer H. Zimmerman Philadelphia District Office Illegal Drug Residue January 21, 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 15, 2013 The Bagel Works Cafe Inc Kansas City District Office CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions 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



-