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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2011 Warning Letters

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Warning Letters issued in 2011

 

* 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
November 18, 2011 Sandoz Incorporated Center for Drug Evaluation and Research CGMP for Finished Pharmaceuticals/Adulterated July 16, 2014
November 18, 2011 Global Sweet Polyols, LLC New England District Office CGMP Regulations For Dietary Supplement/Adulterated Not Issued *
November 18, 2011 Osmed GmbH Center for Devices and Radiological Health Device Adulterated/Misbranded Not Issued *
November 18, 2011 Novartis International AG Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated July 16, 2014
November 17, 2011 B A Howie Inc. New Jersey District Office CGMP for Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions November 02, 2012
November 17, 2011 Crescendo Therapeutics LLC Los Angeles District Office Post-Marketing Adverse Drug Experience (PADE) Not Issued *
November 16, 2011 WellnessOne World, LLC Minneapolis District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated June 21, 2012
November 16, 2011 Sparboe Farms / Prairie Complex Minneapolis District Office PHS Act/Shell Egg Regulation/Adulterated August 19, 2013
November 16, 2011 Rose Stone Enterprises dba Hub Pharmaceuticals LLC Los Angeles District Office Unapproved New Drugs/Misbranded Not Issued *
November 16, 2011 Alexia Foods, Inc Center for Food Safety and Applied Nutrition Food Labeling/Misbranded Not Issued *
November 16, 2011 Innotech USA, Inc Center for Devices and Radiological Health Electronic Product Radiation Control Not Issued *
November 16, 2011 Aranda's Pickled Mushrooms, LLC Minneapolis District Office Acidified Foods/Adulterated Not Issued *
November 16, 2011 Focus Laboratories, Inc Dallas District Office Unapproved New Drugs/Misbranded Not Issued *
November 16, 2011 Altaire Pharmaceuticals, Inc. New York District Office Unapproved New Drugs/Misbranded May 29, 2012
November 16, 2011 Akzo Nobel Chemicals, S.A. de C.V. Center for Drug Evaluation and Research CGMP for Finished Pharmaceuticals/Adulterated June 11, 2012
November 16, 2011 Ming's Food, Inc. Atlanta District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
November 15, 2011 Humpty Dumpty Eggs, Inc Minneapolis District Office PHS Act/Shell Egg Regulation/Adulterated July 30, 2012
November 15, 2011 Reiland, James M. Minneapolis District Office Illegal Drug Residue December 19, 2011
November 15, 2011 Rojas, Inc. Los Angeles District Office Seafood HACCP/Adulterated/Misbranded Not Issued *
November 15, 2011 Xylo Chem Industries Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *



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