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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

2008 Warning Letters

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Warning Letters issued in 2008

 

* 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
September 25, 2008 Forest Laboratories Inc. Center for Drug Evaluation and Research DDMAC/Promotional Claims False & Misleading/Misbranded N/A *
September 25, 2008 Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Center for Drug Evaluation and Research DDMAC/Promotional Claims False & Misleading/Misbranded N/A *
September 25, 2008 Mallinckrodt Inc. Center for Drug Evaluation and Research DDMAC/Promotional Claims False & Misleading/Misbranded N/A *
September 25, 2008 Renewal Research San Francisco District Office Promotional Claims False & Misleading Adulterated/Misbranded N/A *
September 25, 2008 Trident Seafoods, Inc. Seattle District Office Seafood HACCP/GMP for Foods/Adulterated N/A *
September 24, 2008 Fulton Seafood Inc Dallas District Office Seafood HACCP/Adulterated N/A *
September 24, 2008 C Change Surgical, LLC Atlanta District Office CGMP/QSR/Medical Devices/Adulterated N/A *
September 23, 2008 Pharmalucence, Inc. New England District Office CGMP for Finished Pharmaceuticals/Deviations/Adulterated N/A *
September 19, 2008 Meek's Seafood, Inc. New Orleans District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
September 18, 2008 Swiss American Products, Inc. Dallas District Office CGMP/QSR/Medical Devices/Adulterated N/A *
September 17, 2008 Omega Supply Los Angeles District Office New Drug/Labeling/False & Misleading Claims N/A *
September 17, 2008 Technomed Europe Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated N/A *
September 16, 2008 Ranbaxy Laboratories, Ltd., Paonta Sahib, India Center for Drug Evaluation and Research CGMP/Drug/Deviations/Adulterated N/A *
September 16, 2008 Ranbaxy Laboratories, Ltd., Dewas, India Center for Drug Evaluation and Research CGMP/Drug/Deviations/Adulterated N/A *
September 15, 2008 Airsep Corporation New York District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded N/A *
September 11, 2008 A1 Discount Vitamins Dallas District Office DDMAC/Promotional Claims False & Misleading/Misbranded N/A *
September 10, 2008 Stratec Medizintechnik Gmbh Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated N/A *
September 10, 2008 San Mar Manufacturing Corporation San Juan District Office Food Labeling/False & Misleading Claims/Misbranded N/A *
September 05, 2008 Drs. Foster and Smith, Inc. Minneapolis District Office New Animal Drug/Adulterated N/A *
September 05, 2008 Biosafe Laboratories Chicago District Office CGMP/QSR/Medical Devices/Adulterated N/A *



 

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ICECI Warning Letters

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