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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
August 18, 2009 Galderma Laboratories, Inc Center for Drug Evaluation and Research Unapproved New Drugs/Labeling N/A *
August 18, 2009 Hill Dermaceuticals, Inc. Center for Drug Evaluation and Research Prescription Drug Products/Labeling/Misbranded N/A *
August 18, 2009 Core Products Int'L Inc Minneapolis District Office OTC Drug Products/Lacks New Drug Approval/Misbranded N/A *
August 18, 2009 MEKT LLC New Jersey District Office OTC Drug Products/Lacks New Drug Approval/Misbranded N/A *
August 18, 2009 Wonder Laboratories New Orleans District Office OTC Drug Products/Lacks New Drug Approval/Misbranded N/A *
August 18, 2009 BioCentric Laboratories Inc. Denver District Office OTC Drug Products/Lacks New Drug Approval/Misbranded N/A *
August 17, 2009 Continuum Health Partners , Inc. Center for Biologics Evaluation and Research GLP/Bioresearch Monitoring Program N/A *
August 14, 2009 MICA BY THE SEA Center for Food Safety and Applied Nutrition Seafood HACCP/Adulterated N/A *
August 13, 2009 Nitro Pak Preparedness 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.) Philadelphia District Office CGMP for Foods/Seafood HACCP/Adulterated N/A *
August 12, 2009 Cambrex Profarmaco Milano Srl Center for Drug Evaluation and Research CGMP for Drugs/Manufacture, Processing, Packing, Holding/Adulterated N/A *
August 12, 2009 Abbott Molecular Chicago District Office CGMP/QSR/Medical Devices/Adulterated N/A *
August 12, 2009 Hospira Inc San Francisco District Office CGMP/QSR/Medical Devices/Adulterated N/A *
August 11, 2009 Ridge Medical Products LLC Dallas District Office OTC Drug Products/Lacks New Drug Approval/Misbranded N/A *
August 11, 2009 Living Streams Mission, Inc Center for Food Safety and Applied Nutrition Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus N/A *
August 10, 2009 Johnson & Johnson Pharmaceutical Research & Development, LLC Center for Drug Evaluation and Research Sponsor N/A *
August 07, 2009 Universal Taste Inc. Florida District Office Juice/HACCP/Adulterated/Misbranded N/A *
August 05, 2009 Gusto Food, Inc. New York District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
August 05, 2009 Adon Farms New York District Office Illegal Drug Residue N/A *
August 05, 2009 Mexican Village Wholesale Foods, Inc Minneapolis District Office Acidified Foods/Emergency Permit Control/Adulterated/Misbranded N/A *



 

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ICECI Warning Letters

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