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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
September 06, 2011 24/7 Seafood Distributor Corp. Florida District Office CGMP Regulation For Food/Adulterated Not Issued *
September 01, 2011 Deibel Laboratories of Illinois, Inc. Chicago District Office Current Good Manufacturing Practice for Finished Pharmaceuticals/Misbranded/Adulterated November 12, 2013
September 01, 2011 Lonza Biologics, Inc. New England District Office CGMP for Finished Pharmaceuticals/Adulterated Not Issued *
August 31, 2011 The Smokehouse, LLC. d/b/a La Maree Smokehouse New York District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
August 31, 2011 EPI, LLC. Chicago District Office CGMP for Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
August 31, 2011 Luitpold Pharmaceuticals, Inc. New York District Office CGMP for Finished Pharmaceuticals/Adulterated Not Issued *
August 30, 2011 Forsman Farms, Inc Minneapolis District Office PHS Act/Violation September 13, 2012
August 30, 2011 Willharvdoit Corporation Minneapolis District Office CGMP Regulation For Food/Adulterated March 27, 2012
August 29, 2011 South Texas Innovative Medicine Center for Devices and Radiological Health Investigational Device Exemptions (Clinical Investigator) Not Issued *
August 29, 2011 Dakota Pure Water, Inc. Minneapolis District Office CGMP/Processing & Bottling of Bottled Drinking Water Regulations/Adulterated June 05, 2013
August 29, 2011 Beach Products, Inc. Atlanta District Office CGMP Regulation for Finished Pharmaceuticals/Adulterated Not Issued *
August 29, 2011 CHG Hospital Beds, Inc. Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded November 02, 2011
August 26, 2011 Accuron Technologies (Dornier Medtech Systems GmbH ) Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded July 05, 2012
August 26, 2011 Santa Fe Natural Tobacco Company Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded October 14, 2011
August 26, 2011 Micro Distributing II, Ltd. Dallas District Office Medical Device Reporting/Misbranded Not Issued *
August 26, 2011 Caton, John Jr., M.D. Center for Drug Evaluation and Research Clinical Investigator Not Issued *
August 25, 2011 Noven Pharmaceuticals, Inc. Los Angeles District Office CGMP for Finished Pharmaceuticals/Adulterated October 02, 2012
August 25, 2011 Galloway Technologies, L.C. Denver District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
August 25, 2011 Blue Jay Dairy Dallas District Office Illegal Drug Residue Not Issued *
August 25, 2011 Edelweiss Farms, Inc. New York District Office Animal Drug/Adulterated Not Issued *



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