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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
June 03, 2011 Matrixx Initiatives Inc Los Angeles District Office New Drug/Misbranded May 30, 2013
June 02, 2011 Los Genuinos, Inc. San Juan District Office CGMP for Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
June 01, 2011 Tatra Herb Company Philadelphia District Office New Drug/Labeling/Misbranded June 01, 2012
June 01, 2011 Rolf's Patisserie Chicago District Office CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
May 31, 2011 Impax Laboratories, Inc San Francisco District Office CGMP for Finished Pharmaceuticals/Adulterated Not Issued *
May 31, 2011 Butterfly Bakery Inc New Jersey District Office Food Labeling/False & Misleading/Misbranded Not Issued *
May 27, 2011 Euro International Foods, Inc. Seattle District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions April 10, 2012
May 27, 2011 Columbine Specialty Products Inc. Denver District Office CGMP For Manfacturing, Processing, Packing, Storage & Holding/Adulterated Not Issued *
May 27, 2011 AngioDynamics, Inc. New York District Office Medical Device Reporting Regulation/Misbranded Not Issued *
May 27, 2011 Nature Pure LLC Cincinnati District Office PHS Act/Violation January 11, 2012
May 26, 2011 Vipamat Technologie Center for Devices and Radiological Health CGMP for Medical Devices/QSR/Adulterated/Misbranded Not Issued *
May 25, 2011 Cellular Rx Inc Kansas City District Office New Drug/Misbranded Not Issued *
May 25, 2011 Lumen Soy Foods, LLC New Orleans District Office CGMP in Manufacturing, Packing, or Holding Human Food/Adulterated May 24, 2012
May 25, 2011 Ethos Environmental Inc dba Regeneca International Inc Los Angeles District Office Dietary Supplement/Promotional Claims False & Misleading/Adulterated/Misbranded Not Issued *
May 24, 2011 Allure Labs, Inc. San Francisco District Office CGMP for Finished Pharmaceuticals/Misbranded/Adulterated Not Issued *
May 23, 2011 Union Springs Pharmaceuticals, LLC Center for Drug Evaluation and Research Internet Unapproved Drug/Misbranded Not Issued *
May 23, 2011 Knight Feedlot Inc Kansas City District Office CGMP Regulation for Medicated Feeds/Adulterated Not Issued *
May 23, 2011 Cerebral Health, LLC Florida District Office CGMP for Dietary Supplements/Adulterated Not Issued *
May 23, 2011 Compass International Innovations Inc. Minneapolis District Office CGMP/QSR/Medical Devices/Adulterated December 06, 2011
May 20, 2011 Larry Bourdeau / Windy Acres Farm New England District Office Animals for Sale for Slaughter as Food/Adulterated June 21, 2011



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