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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 03, 2009 Clove Cigarettes Shop Center for Tobacco Products Tobacco Products/Adulterated/Misbranded Not Issued *
November 03, 2009 Chavez, Inc. Center for Tobacco Products Tobacco Products/Adulterated/Misbranded November 24, 2009
November 02, 2009 Lim Sin Wei Center for Tobacco Products Tobacco Products/Adulterated Not Issued *
November 02, 2009 Han, Jeffrey Center for Tobacco Products Tobacco Products/Adulterated Not Issued *
November 02, 2009 Li Ning Center for Tobacco Products Tobacco Products/Adulterated/Misbranded Not Issued *
November 02, 2009 Potter, Daniel A., M.D. Center for Devices and Radiological Health Investigational Device Exemptions Not Issued *
November 02, 2009 Smoke Shop USA Ltd Center for Tobacco Products Tobacco Products/Adulterated/Misbranded November 24, 2009
October 30, 2009 LasikPlus Vision Center Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded Not Issued *
October 30, 2009 Lasik Plus Houston Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded Not Issued *
October 30, 2009 TLC Eye Care - Lansing Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded Not Issued *
October 30, 2009 LCA Vision Inc Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded Not Issued *
October 29, 2009 Seoul Shik Poom Inc. New Jersey District Office Seafood HACCP/Misbranded July 28, 2010
October 29, 2009 Sorin Biomedica C.R.M., S.R.L. Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded February 29, 2012
October 29, 2009 Procter and Gamble Center for Drug Evaluation and Research OTC Drug Products/Dietary Supplements/Misbranded Not Issued *
October 28, 2009 Juices International New York District Office CGMP for Foods/Juice HACCP/Adulterated Not Issued *
October 28, 2009 Stew Leonard's Holdings LLC New England District Office Food Labeling/False & Misleading Claims/Misbranded June 10, 2010
October 28, 2009 Double V Dairy Seattle District Office Illegal Drug Residue Not Issued *
October 28, 2009 Perry Veterinary Clinic New York District Office Illegal Drug Residue Not Issued *
October 28, 2009 Almi Inc Philadelphia District Office GMP for Food/Food Labeling/Misbranded/Adulterated Not Issued *
October 27, 2009 American Lifestyle Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus Not Issued *



 

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ICECI Warning Letters

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