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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
August 28, 2008 Koike Seafood, Inc. Seattle District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
August 27, 2008 Fall Prevention Technologies Cincinnati District Office CGMP/QSR/Medical Devices/Adulterated N/A *
August 27, 2008 Sgarlato Laboratories San Francisco District Office CGMP/QSR/Medical Devices/Adulterated N/A *
August 27, 2008 Ziran, Bruce H., MD Center for Devices and Radiological Health Clinical Investigator N/A *
August 25, 2008 A. Tarantino and Sons, Inc. San Francisco District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
August 25, 2008 Ovation Pharmaceuticals, Inc. Center for Biologics Evaluation and Research Promotional Claims/False & Misleading/Misbranded N/A *
August 22, 2008 Health Center for Better Living, Inc. Florida District Office New Drug/Labeling/False & Misleading Claims N/A *
August 21, 2008 Brede, Inc. Detroit District Office CGMP/Deviations For Food Manufacturers/Adulterated N/A *
August 21, 2008 SeniorLife Health Inc. Los Angeles District Office New Drug/Misbranded N/A *
August 21, 2008 SeniorLife Health Inc. Los Angeles District Office New Drug/Labeling/False & Misleading Claims N/A *
August 20, 2008 Suarez Corporation Industries, Inc. Cincinnati District Office Premarket Approval/Misbranded/Adulterated N/A *
August 19, 2008 AliMed Corporation New England District Office CGMP/QSR/Medical Devices/Adulterated N/A *
August 19, 2008 Mission Mountain Food Enterprise Center Seattle District Office Acidified Foods/Adulterated N/A *
August 19, 2008 ONBO Electronics Company Ltd Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated N/A *
August 18, 2008 Fuji System Corp Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated N/A *
August 15, 2008 Hospital Municipal de San Juan Center for Drug Evaluation and Research Institutional Review Board (IRB) N/A *
August 15, 2008 Daniel Chapter One Inc New England District Office New Drug/Labeling/False & Misleading Claims N/A *
August 14, 2008 Prismic Light International, aka Sandent Co. New Orleans District Office Dietary Supplement/Labeling/Misbranded N/A *
August 12, 2008 Mallinckrodt Inc., dba Covidien Kansas City District Office CGMP/Deviations/Adulterated N/A *
August 12, 2008 Capitol Cake Co. Baltimore District Office CGMP Regulation For Food/Adulterated N/A *



 

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ICECI Warning Letters

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