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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
August 19, 2009 MCAA Land & Cattle LLC [ARCHIVED] Detroit District Office Illegal Drug Residue N/A *
August 19, 2009 EFT Inc [ARCHIVED] Los Angeles District Office Dietary Supplements/Adulterated/Misbranded/Labeling N/A *
August 19, 2009 Adelines Inc. [ARCHIVED] New Orleans District Office Seafood HACCP/CGMP/Misbranded N/A *
August 18, 2009 Hill Dermaceuticals, Inc. [ARCHIVED] Center for Drug Evaluation and Research Prescription Drug Products/Labeling/Misbranded N/A *
August 18, 2009 Core Products Int'L Inc [ARCHIVED] Minneapolis District Office OTC Drug Products/Lacks New Drug Approval/Misbranded N/A *
August 18, 2009 MEKT LLC [ARCHIVED] New Jersey District Office OTC Drug Products/Lacks New Drug Approval/Misbranded N/A *
August 18, 2009 Wonder Laboratories [ARCHIVED] New Orleans District Office OTC Drug Products/Lacks New Drug Approval/Misbranded N/A *
August 18, 2009 BioCentric Laboratories Inc. [ARCHIVED] Denver District Office OTC Drug Products/Lacks New Drug Approval/Misbranded N/A *
August 18, 2009 Geromatrix Nutraceutical Corporation [ARCHIVED] Florida District Office OTC Drug Products/Lacks New Drug Approval/Misbranded N/A *
August 18, 2009 Progressive Emu Inc. [ARCHIVED] New Orleans District Office OTC Drug Products/Lacks New Drug Approval/Misbranded N/A *
August 18, 2009 Meditrend, Inc [ARCHIVED] Denver District Office OTC Drug Products/Lacks New Drug Approval/Misbranded N/A *
August 17, 2009 Continuum Health Partners , Inc. [ARCHIVED] Center for Biologics Evaluation and Research Good Laboratory Practice (GLP) N/A *
August 14, 2009 MICA BY THE SEA [ARCHIVED] Center for Food Safety and Applied Nutrition Seafood HACCP/Adulterated N/A *
August 13, 2009 Nitro Pak Preparedness [ARCHIVED] Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
August 13, 2009 Ninth St. Management Inc. (Trades as Superior Pasta Co Inc.) [ARCHIVED] Philadelphia District Office CGMP for Foods/Seafood HACCP/Adulterated N/A *
August 12, 2009 Abbott Molecular [ARCHIVED] Chicago District Office CGMP/QSR/Medical Devices/Adulterated N/A *
August 12, 2009 Cambrex Profarmaco Milano Srl [ARCHIVED] Center for Drug Evaluation and Research CGMP for Drugs/Manufacture, Processing, Packing, Holding/Adulterated N/A *
August 12, 2009 Hospira Inc [ARCHIVED] San Francisco District Office CGMP/QSR/Medical Devices/Adulterated N/A *
August 11, 2009 Living Streams Mission, Inc [ARCHIVED] Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
August 11, 2009 Ridge Medical Products LLC [ARCHIVED] Dallas District Office OTC Drug Products/Lacks New Drug Approval/Misbranded N/A *
August 10, 2009 Johnson & Johnson Pharmaceutical Research & Development, LLC Center for Drug Evaluation and Research Sponsor/Monitor/Contract Research Organization N/A *
August 07, 2009 Universal Taste Inc. [ARCHIVED] Florida District Office Juice/HACCP/Adulterated/Misbranded N/A *
August 05, 2009 Adon Farms [ARCHIVED] New York District Office Illegal Drug Residue N/A *
August 05, 2009 Bayer HealthCare - Bayer Schering Pharma AG [ARCHIVED] Center for Drug Evaluation and Research CGMP for Deviations/Adulterated N/A *
August 05, 2009 Schafer Fisheries, Inc. [ARCHIVED] Chicago District Office Seafood HACCP/Adulterated N/A *
August 05, 2009 Gusto Food, Inc. [ARCHIVED] New York District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
August 05, 2009 Mexican Village Wholesale Foods, Inc [ARCHIVED] Minneapolis District Office Acidified Foods/Emergency Permit Control/Adulterated/Misbranded N/A *
July 31, 2009 Ion Labs, Inc. [ARCHIVED] Florida District Office CGMP for Finished Pharmaceuticals/Adulterated/Misbranded N/A *
July 31, 2009 Byrne Medical, inc. [ARCHIVED] Dallas District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated N/A *
July 31, 2009 G & H Dairy #1, LLC [ARCHIVED] Seattle District Office Illegal Drug Residue N/A *
July 30, 2009 Medical Accessories, Inc. [ARCHIVED] New Jersey District Office CGMP/QSR/Medical Devices/Adulterated N/A *
July 30, 2009 Synflex America Inc [ARCHIVED] Florida District Office New Drug/Adulterated N/A *
July 30, 2009 American Bio Medica Corp [ARCHIVED] Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated N/A *
July 29, 2009 Tcmhelpme [ARCHIVED] Center for Drug Evaluation and Research Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
July 28, 2009 Gadaleto's Seafood Market, Inc. [ARCHIVED] New York District Office Seafood HACCP/GMP for Foods/Adulterated N/A *
July 27, 2009 Lucky Acres [ARCHIVED] Philadelphia District Office Illegal Drug Residue N/A *
July 27, 2009 Bodee LLC [ARCHIVED] Los Angeles District Office Dietary Supplement/Labeling False and Misleading/Misbranded N/A *
July 27, 2009 Harris, Barbara A [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator N/A *
July 27, 2009 Americell-labs.com VMG Global Inc [ARCHIVED] San Francisco District Office Dietary Supplements/Adulterated/Misbranded N/A *
July 24, 2009 Hinsdale Farms, Ltd. [ARCHIVED] Detroit District Office CGMP/Adulterated N/A *
July 24, 2009 ABL - Antibiotics Do Brasil [ARCHIVED] Center for Drug Evaluation and Research CGMP/Adulterated N/A *
July 23, 2009 Chris' Seafood [ARCHIVED] New Orleans District Office CGMP for Foods/Seafood HACCP/Adulterated N/A *
July 23, 2009 Poly Packaging Systems, Inc. [ARCHIVED] New Orleans District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded N/A *
July 22, 2009 Herbal Remedies [ARCHIVED] Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
July 22, 2009 Ohio Medical Corporation [ARCHIVED] Chicago District Office CGMP/QSR/Medical Devices/Adulterated N/A *
July 22, 2009 Q-Based Solutions [ARCHIVED] Center for Drug Evaluation and Research Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
July 20, 2009 Phillips, Robert A., M.D. [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator - Human Trials N/A *
July 17, 2009 La Madeleine Gourmet Foods, Inc. [ARCHIVED] Dallas District Office Seafood HACCP/Adulterated N/A *
July 16, 2009 Thurston, Jeff [ARCHIVED] Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
July 15, 2009 Mgs Soapopular [ARCHIVED] Center for Drug Evaluation and Research Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *

 

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