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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
April 15, 2008 Mlsna Dairy Supply, Inc. Minneapolis District Office Illegal Drug Residue N/A *
April 14, 2008 Pal-Nel Farms Philadelphia District Office Illegal Drug Residue N/A *
April 14, 2008 Torbot Group Inc., Jobskin Division Cincinnati District Office CGMP/QSR/Medical Devices/Adulterated N/A *
April 14, 2008 Lynn Medical Instrument Company Detroit District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated N/A *
April 11, 2008 VIBE Technologies, LLC Denver District Office CGMP/QSR/Medical Devices/Adulterated N/A *
April 11, 2008 Juices Enterprises Inc. New York District Office Juice HACCP/Adulterated N/A *
April 10, 2008 CNS Response Inc Center for Devices and Radiological Health Premarket Approval/Adulterated/Misbranded N/A *
April 10, 2008 Don Tray Industries, Ltd Minneapolis District Office CGMP/QSR/Medical Devices/Adulterated N/A *
April 09, 2008 Simply Fresh Inc. Atlanta District Office CGMP for Foods/Seafood HACCP/Adulterated N/A *
April 09, 2008 John and Maria Nunes Dairy San Francisco District Office Illegal Drug Residue N/A *
April 08, 2008 Pacific Seafood Products, Inc. Florida District Office Seafood HACCP/Adulterated N/A *
April 07, 2008 Asfora, Wilson T. M.D. Center for Devices and Radiological Health Investigational Device Exemptions (Clinical Investigator) N/A *
April 04, 2008 D'Ambrosia, Robert D. M.D. Center for Devices and Radiological Health Investigational Device Exemptions (Clinical Investigator) N/A *
April 03, 2008 Hato Potrero Farm, Inc Florida District Office Promotional Claims False & Misleading/New Drug/Misbranded N/A *
April 01, 2008 Supreme Foods Incorporated Baltimore District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
April 01, 2008 Philips Medical Systems, Inc Cincinnati District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated N/A *
March 28, 2008 Rossmax International Ltd. Center for Devices and Radiological Health CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated N/A *
March 28, 2008 Catalent Pharma Solutions Office of Enforcement CGMP Deviations N/A *
March 26, 2008 Farmacia La Salud Inc. San Juan District Office New Drug/Adulterated/Misbranded/Unapproved N/A *
March 25, 2008 Ophthalmic Technologies, Inc. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated N/A *



 

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