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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2009 Warning Letters

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Warning Letters issued in 2009

 

* Not issued: A close-out letter may issue when, based on FDA’s evaluation, the firm has taken corrective action to address the violations contained in the Warning Letter. This procedure applies to Warning Letters issued on or after September 1, 2009.

* N/A: Not applicable, the Warning Letter was issued prior to September 1, 2009.

Read more about warning and close-out letters

Letter Issue Date Company Name Issuing Office Subject Close Out Date
December 14, 2009 JFD Enterprises Inc Baltimore District Office CGMP Regulation For Food/Adulterated June 06, 2011
December 14, 2009 Chuck's Seafoods, Inc. Seattle District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
December 11, 2009 Teva Parenterals Medicines, Inc. Los Angeles District Office CGMP for Finished Pharmaceuticals/Adulterated October 23, 2012
December 10, 2009 LSG SkyChefs DEN 235 Denver District Office PHS Act & Control of Communicable Diseases & Interstate Conveyance Sanitation Violations Not Issued *
December 10, 2009 Heartsine Technologies Inc Philadelphia District Office Device/Misbranded May 17, 2010
December 10, 2009 Interacoustics A/S Center for Devices and Radiological Health CGMP/QSR/Adulterated/Misbranded Not Issued *
December 09, 2009 www.sharco.tv Center for Biologics Evaluation and Research Biological Products Standards Not Issued *
December 09, 2009 M W Laboratories Inc Atlanta District Office OTC Drug Labeling/New Drug/Misbranded Not Issued *
December 09, 2009 Freeman Manufacturing Company Corporation Detroit District Office Medical Devices/Adulterated/Misbranded Not Issued *
December 08, 2009 Kenshin Trading Corporation Los Angeles District Office Premarket Approval/Misbranded/Adulterated June 28, 2011
December 07, 2009 MyKretek.com Center for Tobacco Products Flavored cigarettes/Misbranded/Adulterated Not Issued *
December 04, 2009 Nestle USA Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Misbranded Not Issued *
December 04, 2009 San Simeon Incorporated Denver District Office Seafood HACCP August 05, 2011
December 03, 2009 Ward, John A., M.D. Center for Drug Evaluation and Research Clinical Investigator Not Issued *
December 03, 2009 P.M.T. Corp Minneapolis District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
December 03, 2009 Z-Medica, LLC New England District Office CGMP/QSR/Medical Devices/Adulterated March 01, 2010
December 03, 2009 Nestle Healthcare Nutrition Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Misbranded Not Issued *
December 01, 2009 Austin Fish Company Atlanta District Office Seafood HACCP Not Issued *
December 01, 2009 Abruzzino's Italian Bakery, LLC Baltimore District Office CGMP Manufacturing, Packing, or Holding Human Food/Adulterated August 13, 2010
December 01, 2009 Village Cannery Of Vermont, Inc. New England District Office CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated March 03, 2010



 

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