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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

Posted on October 07, 2010

Letter Issue Date Company Name Issuing Office Subject Close Out Date
July 21, 2010 Euro Gourmet, Inc. Baltimore District Office Seafood HACCP/Adulterated April 28, 2011
July 21, 2010 Big Daddy's Creamery LLC dba Theno's Dairy Seattle District Office CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated/Misbranded/In sanitary Conditions Not Issued *
July 20, 2010 Haw Par Healthcare Limited Center for Drug Evaluation and Research CGMP for Finished Pharmaceuticals/OTC Drug Manufacturing/Adulterated/Misbranded Not Issued *
July 20, 2010 BCS African Wholesale Food Supply Inc. Minneapolis District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
July 20, 2010 Eminent Spine, LLC Dallas District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
July 19, 2010 Independent Review Consulting, Inc Center for Devices and Radiological Health Institutional Review Board (IRB) Not Issued *
July 19, 2010 BCIW Inc. Los Angeles District Office CGMP/QSR/Medical Device Reporting/Misbranded May 11, 2012
July 16, 2010 ARJ Medical, Inc. Florida District Office CGMP for Medical Devices/QS/Adulterated Not Issued *
July 15, 2010 Knott's Wholesale Foods, Inc. New Orleans District Office Acidified Foods/Emergency Permit Control/Adulterated/Misbranded June 02, 2011
July 15, 2010 Shah Distributors, Inc. Los Angeles District Office CGMP Regulation For Food/Adulterated Not Issued *


 

Contact FDA

301-796-8490
FDA's Office of Critical Path Programs
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