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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

 
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Letter Issue Date Company Name Issuing Office Subject Close Out Date
11/09/2009 Dallas Jr, Anthony V, MD [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator Not Issued *
11/09/2009 Provident Pharmaceuticals LLC [ARCHIVED] Denver District Office CGMP for Finished Pharmaceuticals/Misbranded/Adulterated Not Issued *
11/09/2009 Medtronic Inc. Cardiac Rhythm Disease Managment [ARCHIVED] Minneapolis District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
11/06/2009 ELA Medical S.A.S. [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Medical Device Reporting/Misbranded 02/29/2012
11/06/2009 Valley Harvest Nut Company [ARCHIVED] San Francisco District Office CGMP Regulation For Food/Adulterated 06/22/2010
11/06/2009 Dynamic Nutritional Associates [ARCHIVED] Seattle District Office Labeling/False & Misleading Claims/Misbranded Not Issued *
11/04/2009 Solar Farms, Inc. [ARCHIVED] Atlanta District Office CGMP For Human Food, Prepared,Packed, or Held under Insanitary Conditions/Adulterated Not Issued *
11/04/2009 Silver Soft for Skin [ARCHIVED] Center for Drug Evaluation and Research Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus Not Issued *
11/03/2009 Gibson Laboratories Inc [ARCHIVED] Cincinnati District Office CGMP for Medical Devices/QS/Adulterated 08/04/2010
11/03/2009 Durango Smoke Shop, Inc. [ARCHIVED] Center for Tobacco Products Tobacco Products/Adulterated/Misbranded 01/12/2010
11/03/2009 Culinaire Incorporated [ARCHIVED] Denver District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
11/03/2009 Texas Wholesale [ARCHIVED] Center for Tobacco Products Tobacco Products/Adulterated/Misbranded 11/24/2009
11/03/2009 Chavez, Inc. [ARCHIVED] Center for Tobacco Products Tobacco Products/Adulterated/Misbranded 11/24/2009
11/03/2009 Clove Cigarettes Shop [ARCHIVED] Center for Tobacco Products Tobacco Products/Adulterated/Misbranded Not Issued *
11/03/2009 Euro-Cigs [ARCHIVED] Center for Tobacco Products Tobacco Products/Adulterated/Misbranded Not Issued *
11/03/2009 Amsterdam Tobacco Co [ARCHIVED] Center for Tobacco Products Tobacco Products/Adulterated/Misbranded 12/02/2010
11/03/2009 Rokok Zone [ARCHIVED] Center for Tobacco Products Tobacco Products/Adulterated/Misbranded Not Issued *
11/03/2009 Heavenly Smoke Inc [ARCHIVED] Center for Tobacco Products Tobacco Products/Adulterated/Misbranded 12/02/2010
11/03/2009 Algisiya Servicesz Limited [ARCHIVED] Center for Tobacco Products Tobacco Products/Adulterated Not Issued *
11/03/2009 H.J. Bailey Co. [ARCHIVED] Center for Tobacco Products Tobacco Products/Adulterated 11/24/2009
11/02/2009 Li Ning [ARCHIVED] Center for Tobacco Products Tobacco Products/Adulterated/Misbranded Not Issued *
11/02/2009 Han, Jeffrey [ARCHIVED] Center for Tobacco Products Tobacco Products/Adulterated Not Issued *
11/02/2009 Smoke Shop USA Ltd [ARCHIVED] Center for Tobacco Products Tobacco Products/Adulterated/Misbranded 11/24/2009
11/02/2009 Lim Sin Wei [ARCHIVED] Center for Tobacco Products Tobacco Products/Adulterated Not Issued *
10/30/2009 LCA Vision Inc [ARCHIVED] Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded Not Issued *
10/30/2009 LasikPlus Vision Center [ARCHIVED] Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded Not Issued *
10/30/2009 Lasik Plus Houston [ARCHIVED] Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded Not Issued *
10/30/2009 TLC Eye Care - Lansing [ARCHIVED] Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded Not Issued *
10/29/2009 Sorin Biomedica C.R.M., S.R.L. [ARCHIVED] Center for Devices and Radiological Health Medical Device Reporting Regulation/Misbranded 02/29/2012
10/29/2009 Seoul Shik Poom Inc. [ARCHIVED] New Jersey District Office Seafood HACCP/Misbranded 07/28/2010
10/29/2009 Procter and Gamble [ARCHIVED] Center for Drug Evaluation and Research OTC Drug Products/Dietary Supplements/Misbranded Not Issued *
10/28/2009 Almi Inc [ARCHIVED] Philadelphia District Office GMP for Food/Food Labeling/Misbranded/Adulterated Not Issued *
10/28/2009 Perry Veterinary Clinic [ARCHIVED] New York District Office Illegal Drug Residue Not Issued *
10/28/2009 Stew Leonard's Holdings LLC [ARCHIVED] New England District Office Food Labeling/False & Misleading Claims/Misbranded 06/10/2010
10/28/2009 Double V Dairy [ARCHIVED] Seattle District Office Illegal Drug Residue Not Issued *
10/28/2009 Juices International [ARCHIVED] New York District Office CGMP for Foods/Juice HACCP/Adulterated Not Issued *
10/27/2009 American Lifestyle [ARCHIVED] Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus Not Issued *
10/26/2009 King Systems Corp. [ARCHIVED] Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated Not Issued *
10/26/2009 Thermography and Breast Health Center of Idaho [ARCHIVED] Center for Devices and Radiological Health Premarket Approval/Adulterated Not Issued *
10/23/2009 ZaCh System S.A. [ARCHIVED] Center for Drug Evaluation and Research CGMP Manufacture, Processing, Packing or Holding/Adulterated 04/12/2011
10/23/2009 McKay, Charles M.D. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator Not Issued *
10/22/2009 Endotec, Inc. [ARCHIVED] Florida District Office CGMP/QSR/Adulterated/Misbranded Not Issued *
10/22/2009 Vander Horst Dairy and Farming Dallas District Office Illegal Drug Residue 11/12/2010
10/21/2009 Minatare Feed Lot Inc [ARCHIVED] Kansas City District Office CGMP for Medicated Feeds/Adulterated Not Issued *
10/19/2009 MI Hope Inc. dba Center for Complex Infectious Diseases IRB [ARCHIVED] Center for Drug Evaluation and Research Institutional Review Board (IRB) Not Issued *
10/16/2009 Pacific American Fish Co., Inc [ARCHIVED] New England District Office CGMP for Foods/Seafood HACCP/Adulterated 03/11/2010
10/16/2009 Trilogy Crab Co. Inc. [ARCHIVED] Seattle District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
10/16/2009 Schwarz Fish Co. [ARCHIVED] Minneapolis District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 04/13/2012
10/16/2009 Okami, Incorporated [ARCHIVED] Denver District Office CGMP for Foods/Seafood HACCP/Adulterated 12/01/2010
10/15/2009 Weil Lifestyle LLC [ARCHIVED] Center for Biologics Evaluation and Research Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus Not Issued *

 

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