-

Inspections, Compliance, Enforcement, and Criminal Investigations

Section Contents Menu

-

2009 Warning Letters

Recently Posted |2010 | 2009 | 2008 | 2007 | 2006 | 2005 | 2004 | 2003 | 2002 | 2001 | 2000 | 1999 | 1998 | 1997 | 1996

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
December 31, 2009 Penumbra, Inc. San Francisco District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
December 29, 2009 Crothall Healthcare, Inc. New Orleans District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
December 28, 2009 Branan Medical Corp. Inc. Los Angeles District Office Premarket Approval/Misbranded/Adulterated Not Issued *
December 24, 2009 Micro Current Technology, Inc. Seattle District Office Device Lacks Marketing Clearance Approval/Adulterated/Misbranded Not Issued *
December 23, 2009 Grupo Alimentario Del Atlantico Sa "Gralco Sa" Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
December 23, 2009 Arteriocyte Medical Systems Inc Center for Biologics Evaluation and Research Device/Lacks Approved Premarket Application/Adulterated/Misbranded Not Issued *
December 21, 2009 Paul W. Marks Co., Inc New England District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
December 21, 2009 Victus, Inc. Florida District Office Medical Device/CGMP Requirements of Quality System Regulation Not Issued *
December 21, 2009 Ohm Laboratories, Inc. New York District Office CGMP for Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *
December 17, 2009 Florida Atlantic University IRB Center for Devices and Radiological Health Institutional Review Board (IRB) Not Issued *
December 15, 2009 Sibley Memorial Hospital Baltimore District Office CGMP for Blood & Blood Products/Adulterated Not Issued *
December 15, 2009 Awesome Foods, Inc. Philadelphia District Office Food Labeling/Misbranded Not Issued *
December 15, 2009 Micromed Technology, Inc Center for Devices and Radiological Health Medical Device Reporting/Misbranded Not Issued *
December 14, 2009 Millenkamp Cattle Seattle District Office Animal Sale for Slaughter as Food/Adulterated Not Issued *
December 14, 2009 Chuck's Seafoods, Inc. Seattle District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
December 14, 2009 JFD Enterprises Inc Baltimore District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
December 14, 2009 Burgos Burgos Corp. Baltimore District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
December 14, 2009 Langit Bali Center for Tobacco Products Tobacco Products/Adulterated/Misbranded Not Issued *
December 14, 2009 Indonesia Clove Cigarettes Center for Tobacco Products Tobacco Products/Adulterated/Misbranded Not Issued *
December 10, 2009 LSG SkyChefs DEN 235 Denver District Office PHS Act & Control of Communicable Diseases & Interstate Conveyance Sanitation Violations Not Issued *
December 09, 2009 Freeman Manufacturing Company Corporation Detroit District Office Medical Devices/Adulterated/Misbranded Not Issued *
December 08, 2009 Kenshin Trading Corporation Los Angeles District Office Premarket Approval/Misbranded/Adulterated Not Issued *
December 07, 2009 MyKretek.com Center for Tobacco Products Flavored cigarettes/Misbranded/Adulterated Not Issued *
December 04, 2009 San Simeon Incorporated Denver District Office Seafood HACCP Not Issued *
December 04, 2009 Nestle USA Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Misbranded Not Issued *
December 03, 2009 Ward, John A., M.D. Center for Drug Evaluation and Research Clinical Investigator Not Issued *
December 03, 2009 P.M.T. Corp Minneapolis District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
December 03, 2009 Nestle Healthcare Nutrition Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Misbranded Not Issued *
December 01, 2009 www.secretsofbetterhealth.com dba My Cosmetic Company Center for Drug Evaluation and Research Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus Not Issued *
December 01, 2009 Village Cannery Of Vermont, Inc. New England District Office CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated Not Issued *
December 01, 2009 Tetracore, Inc. Baltimore District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
December 01, 2009 Abruzzino's Italian Bakery, LLC Baltimore District Office CGMP Manufacturing, Packing, or Holding Human Food/Adulterated Not Issued *
November 30, 2009 www.bestswinefluvaccine.com Center for Biologics Evaluation and Research Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus Not Issued *
November 30, 2009 Aregenius Worldwide LLC Center for Drug Evaluation and Research Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus Not Issued *
November 30, 2009 Aluwe, LLC Minneapolis District Office Unapproved New Drug/Misbranded Not Issued *
November 30, 2009 Chaur Fong Inc. dba 888 Food Company Los Angeles District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
November 30, 2009 Hyde Park Holistic Center Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus Not Issued *
November 27, 2009 ICON Clinical Research, Inc. Center for Drug Evaluation and Research Bioresearch Monitoring Program Not Issued *
November 27, 2009 GDMI, Inc Dallas District Office CGMP for Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *
November 27, 2009 CFM dba Your Deli Florida District Office Seafood/HACCP/CGMP for Foods/Adulterated Not Issued *
November 24, 2009 Gazda, Thomas M.D. Center for Drug Evaluation and Research Clinical Investigator Not Issued *
November 24, 2009 Buettner, Craig M., MD Center for Drug Evaluation and Research Clinical Investigator Not Issued *
November 24, 2009 U.F. Union International Food Company San Francisco District Office CGMP/Deviations/Adulterated Not Issued *
November 23, 2009 Quesnel Livestock New England District Office Animal Sale for Slaughter as Food/Adulterated Not Issued *
November 20, 2009 Centra Health Inc Irb Center for Devices and Radiological Health Investigational Device Exemptions Not Issued *
November 20, 2009 Microsulis Medical Ltd. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
November 20, 2009 Pan American Laboratories, LLC Center for Food Safety and Applied Nutrition Dietary Supplement/Labeling/False & Misleading Claims/Misbranded Not Issued *
November 20, 2009 Wellspring International, Inc. Minneapolis District Office Unapproved New Drug Not Issued *
November 20, 2009 Huaiyin Medical Instruments Co., Ltd. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
November 19, 2009 United Fish Distributors, Inc. Detroit District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12  [next]
-
 

Contact Us

    Division of Freedom of Information (HFI-35)

    Food and Drug Administration

    5600 Fishers Lane

    Rockville, MD 20857

-
-
-
  • Share  Email this Page
-
-
-