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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

    Posted on January 12, 2010

    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 September 21, 2010
    December 29, 2009 Crothall Healthcare, Inc. New Orleans District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded July 29, 2011
    December 28, 2009 Branan Medical Corp. Inc. Los Angeles District Office Premarket Approval/Misbranded/Adulterated May 17, 2012
    December 24, 2009 Micro Current Technology, Inc. Seattle District Office Device Lacks Marketing Clearance Approval/Adulterated/Misbranded Not Issued *
    December 23, 2009 Arteriocyte Medical Systems Inc Center for Biologics Evaluation and Research Device/Lacks Approved Premarket Application/Adulterated/Misbranded February 17, 2010
    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 Genetics & IVF Institute IRB Center for Devices and Radiological Health Institutional Review Board (IRB) Not Issued *
    December 22, 2009 Balchem Corporation Chicago District Office Current Good Manufacturing Practice Regulation for Finished Pharmaceuticals August 18, 2010
    December 21, 2009 Victus, Inc. Florida District Office Medical Device/CGMP Requirements of Quality System Regulation October 07, 2010
    December 21, 2009 Ohm Laboratories, Inc. New York District Office CGMP for Finished Pharmaceuticals/Adulterated Not Issued *
    December 21, 2009 Paul W. Marks Co., Inc New England District Office Seafood HACCP/CGMP for Foods/Adulterated April 29, 2010
    December 17, 2009 Florida Atlantic University IRB Center for Devices and Radiological Health Institutional Review Board (IRB) Not Issued *
    December 16, 2009 Sushi On a Roll, Inc Los Angeles District Office CGMP for Foods/Seafood HACCP/Adulterated Not Issued *
    December 15, 2009 Micromed Technology, Inc Center for Devices and Radiological Health Medical Device Reporting/Misbranded Not Issued *
    December 15, 2009 Awesome Foods, Inc. Philadelphia District Office Food Labeling/Misbranded April 30, 2010
    December 15, 2009 Sibley Memorial Hospital Baltimore District Office CGMP for Blood & Blood Products/Adulterated Not Issued *
    December 14, 2009 Burgos Burgos Corp. Baltimore District Office Seafood HACCP/CGMP for Foods/Adulterated June 08, 2011
    December 14, 2009 Indonesia Clove Cigarettes Center for Tobacco Products Tobacco Products/Adulterated/Misbranded Not Issued *
    December 14, 2009 Langit Bali Center for Tobacco Products Tobacco Products/Adulterated/Misbranded Not Issued *
    December 14, 2009 JFD Enterprises Inc Baltimore District Office CGMP Regulation For Food/Adulterated June 06, 2011
    December 14, 2009 Chuck's Seafoods, Inc. Seattle District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
    December 14, 2009 Millenkamp Cattle Seattle District Office Illegal Drug Residue Not Issued *
    December 11, 2009 Teva Parenterals Medicines, Inc. Los Angeles District Office CGMP for Finished Pharmaceuticals/Adulterated Not Issued *
    December 10, 2009 Heartsine Technologies Inc Philadelphia District Office Device/Misbranded May 17, 2010
    December 10, 2009 LSG SkyChefs DEN 235 Denver District Office PHS Act & Control of Communicable Diseases & Interstate Conveyance Sanitation Violations Not Issued *
    December 10, 2009 Interacoustics A/S Center for Devices and Radiological Health CGMP/QSR/Adulterated/Misbranded Not Issued *
    December 09, 2009 M W Laboratories Inc Atlanta District Office OTC Drug Labeling/New Drug/Misbranded Not Issued *
    December 09, 2009 www.sharco.tv Center for Biologics Evaluation and Research Biological Products Standards 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 June 28, 2011
    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 August 05, 2011
    December 04, 2009 Nestle USA Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Misbranded Not Issued *
    December 03, 2009 P.M.T. Corp Minneapolis District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
    December 03, 2009 Ward, John A., M.D. Center for Drug Evaluation and Research Clinical Investigator Not Issued *
    December 03, 2009 Z-Medica, LLC New England District Office CGMP/QSR/Medical Devices/Adulterated March 01, 2010
    December 03, 2009 Nestle Healthcare Nutrition Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Misbranded Not Issued *
    December 01, 2009 Abruzzino's Italian Bakery, LLC Baltimore District Office CGMP Manufacturing, Packing, or Holding Human Food/Adulterated August 13, 2010
    December 01, 2009 Tetracore, Inc. Baltimore District Office CGMP/QSR/Medical Devices/Adulterated August 23, 2010
    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 Austin Fish Company Atlanta District Office Seafood HACCP Not Issued *
    December 01, 2009 Village Cannery Of Vermont, Inc. New England District Office CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated March 03, 2010
    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 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 www.bestswinefluvaccine.com Center for Biologics 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 27, 2009 GDMI, Inc Dallas District Office CGMP for Finished Pharmaceuticals/Adulterated/Misbranded Not Issued *
    November 27, 2009 ICON Clinical Research, Inc. Center for Drug Evaluation and Research Sponsor-Applicant-Monitor-Clinical Research Organization Not Issued *
    November 27, 2009 CFM dba Your Deli Florida District Office Seafood/HACCP/CGMP for Foods/Adulterated Not Issued *


     

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    ICECI Warning Letters

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