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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
July 21, 2010 U.F.S. Industries, Inc. (d/b/a) Sally Sherman Foods New York District Office Seafood HACCP/CGMP for Foods/Adulterated January 20, 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 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 February 06, 2012
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 19, 2010 BCIW Inc. Los Angeles District Office CGMP/QSR/Medical Device Reporting/Misbranded May 11, 2012
July 19, 2010 Independent Review Consulting, Inc Center for Devices and Radiological Health Institutional Review Board (IRB) Not Issued *
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 *
July 15, 2010 RT Naturals, LLC Los Angeles District Office Unapproved New Drug/Misbranded Not Issued *
July 14, 2010 VertiFlex, Inc. Los Angeles District Office Premarket Approval/Adulterated December 15, 2010
July 13, 2010 Hill, Brian & Barbara Chicago District Office Animal Sale for Slaughter as Food/Adulterated Not Issued *
July 13, 2010 Cincinnati Sub-Zero Products Inc Cincinnati District Office CGMP For Manfacturing, Processing, Packing, Storage & Holding/Adulterated January 17, 2012
July 12, 2010 Circulatory Technology Inc New York District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated February 17, 2012
July 12, 2010 Amstech Incorporated Center for Devices and Radiological Health Electronic Product Radiation Control Not Issued *
July 09, 2010 Beckman, Robert L. New York District Office Animal Sale for Slaughter as Food/Adulterated Not Issued *
July 09, 2010 Med Prep Consulting, Inc New Jersey District Office Failure to Register and List/Misbranded Not Issued *
July 08, 2010 Florida Bottling, Inc. Florida District Office New Drug/Drug Labeling/Misbranded March 31, 2011
July 06, 2010 Country Road Veterinary Services LLC Cincinnati District Office New Animal Drug/Adulterated/Labeling/Misbranded September 01, 2010



 

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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