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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2009 Warning Letters

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Warning Letters issued in 2009

 

* 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 09, 2009 Medtronic Inc. Cardiac Rhythm Disease Managment Minneapolis District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
November 09, 2009 Provident Pharmaceuticals LLC Denver District Office CGMP for Finished Pharmaceuticals/Misbranded/Adulterated Not Issued *
November 09, 2009 Dallas Jr, Anthony V, MD Center for Drug Evaluation and Research Clinical Investigator Not Issued *
November 09, 2009 Scotty's, Inc. Detroit District Office CGMP Manufacturing, Packing, or Holding Human Food/Adulterated May 12, 2011
November 06, 2009 ELA Medical S.A.S. Center for Devices and Radiological Health CGMP/QSR/Medical Device Reporting/Misbranded February 29, 2012
November 06, 2009 Dynamic Nutritional Associates Seattle District Office Labeling/False & Misleading Claims/Misbranded Not Issued *
November 06, 2009 Eisai Medical Research, Inc. Center for Drug Evaluation and Research DDMAC/Promotional Claims False & Misleading/Misbranded Not Issued *
November 06, 2009 Valley Harvest Nut Company San Francisco District Office CGMP Regulation For Food/Adulterated June 22, 2010
November 04, 2009 Silver Soft for Skin Center for Drug Evaluation and Research Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus Not Issued *
November 04, 2009 Solar Farms, Inc. Atlanta District Office CGMP For Human Food, Prepared,Packed, or Held under Insanitary Conditions/Adulterated Not Issued *
November 03, 2009 H.J. Bailey Co. Center for Tobacco Products Tobacco Products/Adulterated November 24, 2009
November 03, 2009 Amsterdam Tobacco Co Center for Tobacco Products Tobacco Products/Adulterated/Misbranded December 02, 2010
November 03, 2009 Gibson Laboratories Inc Cincinnati District Office CGMP for Medical Devices/QS/Adulterated August 04, 2010
November 03, 2009 Durango Smoke Shop, Inc. Center for Tobacco Products Tobacco Products/Adulterated/Misbranded January 12, 2010
November 03, 2009 Culinaire Incorporated Denver District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
November 03, 2009 Texas Wholesale Center for Tobacco Products Tobacco Products/Adulterated/Misbranded November 24, 2009
November 03, 2009 Algisiya Servicesz Limited Center for Tobacco Products Tobacco Products/Adulterated Not Issued *
November 03, 2009 Heavenly Smoke Inc Center for Tobacco Products Tobacco Products/Adulterated/Misbranded December 02, 2010
November 03, 2009 Rokok Zone Center for Tobacco Products Tobacco Products/Adulterated/Misbranded Not Issued *
November 03, 2009 Euro-Cigs Center for Tobacco Products Tobacco Products/Adulterated/Misbranded Not Issued *



 

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ICECI Warning Letters

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