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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
July 23, 2008 Husain, Mustafa M, M.D. Center for Devices and Radiological Health Clinical Investigator N/A *
July 23, 2008 Simmons Pet Food, Inc. Dallas District Office Deviations From Low Acid Canned Food Regulation/Adulterated N/A *
July 22, 2008 C.R. Bard, Inc. San Juan District Office CGMP/QSR/Medical Devices/Adulterated N/A *
July 18, 2008 Tony & Sons Seafood Corp. New York District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
July 17, 2008 Shirk, Clarence W, Philadelphia District Office Illegal Drug Residue N/A *
July 17, 2008 Washington County Livestock Center, Inc. Cincinnati District Office Illegal Drug Residue N/A *
July 16, 2008 ReBuilder Medical Technologies, Inc. Center for Devices and Radiological Health Premarket Approval/Misbranded/Adulterated N/A *
July 15, 2008 X Spine Systems, Inc. Cincinnati District Office CGMP/QSR/Medical Devices/Adulterated N/A *
July 15, 2008 Mesquite Diagnostics Dallas District Office Mammography Quality Standards Act N/A *
July 14, 2008 Schroeder Industries, Inc. Dallas District Office CGMP/QSR/Medical Devices/Adulterated N/A *
July 14, 2008 Blue Pacific Seafood, Inc. (DBA Shrimp Works, aka Water Works) Dallas District Office Seafood HACCP/GMP for Foods/Adulterated N/A *
July 10, 2008 Baker's Breakfast Cookie, Inc. Seattle District Office Food Labeling/False & Misleading Claims/Misbranded N/A *
July 09, 2008 Tattva's Herbs, LLC Seattle District Office Promotional Claims False & Misleading/Misbranded N/A *
July 09, 2008 Sharp Labs Inc Florida District Office New Drug/Labeling/False & Misleading Claims N/A *
July 08, 2008 Bowers, James H. Jr., M.D. Center for Devices and Radiological Health Institutional Review Board (IRB) N/A *
July 08, 2008 Dairyland Farm, LLC Minneapolis District Office Illegal Drug Residue N/A *
July 08, 2008 Morey's Seafood International, LLC Minneapolis District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
July 07, 2008 Volk Optical, Inc. Cincinnati District Office CGMP/QSR/Medical Devices/Adulterated N/A *
July 07, 2008 Hiroshi's Enterprises, Inc. Seattle District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
July 03, 2008 Carematrix, Inc. Chicago District Office CGMP/QSR/Medical Devices/Adulterated N/A *



 

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