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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

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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

Posted on April 12, 2011

Letter Issue Date Company Name Issuing Office Subject Close Out Date
March 25, 2011 Day Boat Seafood LLC Florida District Office CGMP for Foods/Seafood HACCP/Adulterated Not Issued *
March 25, 2011 True World Food Boston, LLC New England District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions August 30, 2011
March 24, 2011 American Association of Acupuncture and Bio-Energetic Medicine Center for Devices and Radiological Health Investigational Review Board (IRB) Not Issued *
March 24, 2011 Express Diagnostics International, Inc. Minneapolis District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated October 14, 2011
March 24, 2011 Jonathan's Sprouts Inc. New England District Office Labeling/New Drug/Misbranded June 22, 2011
March 24, 2011 Air Wisconsin Airlines Corporation Philadelphia District Office Interstate Conveyance Sanitation Regulations October 04, 2011
March 24, 2011 Valor Medical Inc Center for Devices and Radiological Health Investigational Device Exemptions (Sponsor) Not Issued *
March 23, 2011 Jonlly Fruits, Inc. San Juan District Office CGMP Regulation for Foods/Juice HACCP/Adulterated Not Issued *
March 23, 2011 BC Group International, Inc. Kansas City District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated January 06, 2012
March 22, 2011 DiaPharma Group Inc Cincinnati District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
March 22, 2011 Zimmerman, Mark S. Philadelphia District Office Animals Sale for Slaughter as Food/Adulterated Not Issued *
March 22, 2011 Meditherm Inc. Center for Devices and Radiological Health False & Misleading Claims/Misbranded. Not Issued *
March 22, 2011 Dixie Mills, LLC Atlanta District Office CGMP Regulations for Food/Adulterated Not Issued *
March 21, 2011 Zaiac, Martin N. Center for Drug Evaluation and Research Clinical Investigator Not Issued *
March 21, 2011 Horowitz, Jeffrey M.D. Center for Drug Evaluation and Research Clinical Investigator Not Issued *
March 18, 2011 Non-Invasive Monitoring Systems, Inc. Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
March 18, 2011 Caridian BCT Inc. Denver District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated November 21, 2011
March 18, 2011 Pt. Indomaguro Tunas Unggul Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
March 18, 2011 Horizon Acres Cincinnati District Office Animals for Sale for Slaughter as Food/Adulterated Not Issued *
March 17, 2011 Dakota Laboratories, Llc Minneapolis District Office CGMP for Finished Pharmaceuticals/Adulterated Not Issued *


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