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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
July 27, 2011 La Villa Tortilleria, Inc. New Orleans District Office CGMP For Manfacturing, Processing, Packing, Storage & Holding/Adulterated Not Issued *
July 27, 2011 Gulf Medical Fiberoptics, Inc. Florida District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
July 27, 2011 Diana Fruit Company Incorporated San Francisco District Office Acidified Foods/Acid Canned Food Regulation/Adulterated October 11, 2012
July 27, 2011 Bionet Co., Ltd. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
July 26, 2011 Essex Institutional Review Board, Inc Center for Drug Evaluation and Research Investigational Review Board (IRB) Not Issued *
July 26, 2011 Edenic Soy & Tofu, Inc Chicago District Office CGMP for Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
July 26, 2011 Laboratorios B. Braun S.A Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated and Medical Device Reporting/Misbranded Not Issued *
July 26, 2011 D & D Catering, Inc. Florida District Office CGMP for Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions March 16, 2012
July 25, 2011 Spinetronics, LLC Florida District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
July 22, 2011 Bagels Forever, Inc Minneapolis District Office CGMP in Manufacturing, Packing, or Holding Human Food/Adulterated January 26, 2012
July 22, 2011 Great American Deli New Orleans District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
July 21, 2011 Capt'n Chuncky's Crab Cake Company, LLC Philadelphia District Office Seafood HACCP/Adulterated/Misbranded January 06, 2012
July 21, 2011 Sam's Marketing Inc. dba CoCo’s Fish Market San Francisco District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
July 20, 2011 SpecLinc, Inc. New Orleans District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Not Issued *
July 20, 2011 Danny Johnson Cincinnati District Office Illegal Drug Residue December 15, 2011
July 20, 2011 Electro-Cap International, Inc. Cincinnati District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Not Issued *
July 19, 2011 Linda D. Bosserman Center for Drug Evaluation and Research Clinical Investigator Not Issued *
July 19, 2011 Yamaya USA Inc. Los Angeles District Office Seafood HACCP/Adulterated Not Issued *
July 18, 2011 Isis Services, LLC Center for Devices and Radiological Health Investigational Device Exemptions (IDE) February 07, 2013
July 18, 2011 Pacific Food, Inc Cincinnati District Office Seafood HACCP/Adulterated/Misbranded Not Issued *



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