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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

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
January 13, 2011 Franklin Foods Inc. New England District Office Seafood HACCP/Adulterated July 07, 2011
January 12, 2011 PROLAC, INC. San Juan District Office CGMP/Manufacturing, Packing & Holding Human Food/Misbranded Not Issued *
January 11, 2011 California Delights, Inc. San Francisco District Office CGMP for Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
January 11, 2011 Alphatec Spine, Inc. Center for Devices and Radiological Health Device/Misbranded Not Issued *
January 10, 2011 Vander Schaaf Dairy #2 San Francisco District Office Animals for Sale for Slaughter as Food/Adulterated Not Issued *
January 10, 2011 Gyrus Medical Center for Devices and Radiological Health Medical Device Reporting/Misbranded Not Issued *
January 07, 2011 Azteca Linda Corp New York District Office CGMP for Foods/Adulterated April 22, 2011
January 07, 2011 Benz's Food Products Inc. New York District Office Seafood HACCP/CGMP for Foods/Adulterated September 29, 2011
January 06, 2011 Flir System AB Center for Devices and Radiological Health Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Not Issued *
January 06, 2011 Orthocon Inc Center for Devices and Radiological Health Investigational Device Exemptions (IDE)/Premarket Approval Application [PMA] Not Issued *
January 06, 2011 National Federation Of Fisheries Co-Operatives Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
January 05, 2011 Inter-Ocean Seafood Traders Inc San Francisco District Office Seafood HACCP February 28, 2013
January 05, 2011 Rowley's South Ridge Farms, Inc. Denver District Office Juice/HACCP/Adulterated Not Issued *



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