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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2010 Warning Letters

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Warning Letters issued in 2010

 

* 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
November 03, 2010 Energy Technology Development Ltd./Wicked Lasers Center for Devices and Radiological Health Quality Control & Testing Program Not Issued *
November 03, 2010 Meiko Food Company Inc. Los Angeles District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions September 18, 2012
November 02, 2010 Dreisbach Enterprises Inc. San Francisco District Office Seafood HACCP Not Issued *
November 01, 2010 Eckerd Seafood, Inc. Atlanta District Office Seafood HACCP Not Issued *
November 01, 2010 Hong's Merchandising Group, Inc. New York District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
November 01, 2010 Vitality Products Company Inc. Philadelphia District Office Misbranded/Labeling/Unauthorized Health Claims April 28, 2011
November 01, 2010 Kashmir Crown Baking LLC New Jersey District Office CGMP Regulation For Food/Adulterated June 09, 2011
November 01, 2010 Claris Lifesciences Limited Center for Drug Evaluation and Research CGMP for Finished Pharmaceutical/Unapproved New Drugs/Adulterated August 14, 2012
November 01, 2010 Bioenergy, Inc Minneapolis District Office Labeling/False & Misleading Claims/Misbranded August 29, 2011
November 01, 2010 Kashmir Crown Baking LLC New Jersey District Office CGMP Regulation For Food/Adulterated Not Issued *
October 29, 2010 CP Pharmaceuticals, Ltd. Center for Drug Evaluation and Research CGMP for Finished Pharmaceuticals/Adulterated July 23, 2012
October 28, 2010 Wright Family Dairy Atlanta District Office Animals for Sale for Slaughter as Food/Adulterated Not Issued *
October 27, 2010 Mexicali Cheese Corp. New York District Office CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated Not Issued *
October 27, 2010 Russell C. Davis Planetarium Center for Devices and Radiological Health Laser Product Performance Standard Not Issued *
October 26, 2010 Pega Medical Inc. Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded Not Issued *
October 26, 2010 Bay Island, Inc. Minneapolis District Office CGMP for Foods/Adulterated January 31, 2012
October 22, 2010 Pesnusan Cia Ltda Center for Food Safety and Applied Nutrition CGMP for Foods/Seafood HACCP/Adulterated April 21, 2011
October 21, 2010 Hong Chang Corporation Los Angeles District Office CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated/Insanitary Conditions Not Issued *
October 21, 2010 Hanover Foods Corporation Baltimore District Office CGMP Regulation For Food/Adulterated Not Issued *
October 21, 2010 Nobel Laboratories, LLC Dallas District Office Unapproved New Drug Promotional Claims/Misbranded Not Issued *



 

Contact FDA

FDA's Office of Critical Path and Regulatory Science Initiatives

Frank F. Weichold, MD, PhD

Acting Director

Critical Path and Regulatory Science Initiatives

301-796-8187

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