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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2010 Warning Letters

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Warning Letters issued in 2010

 

* 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

Posted on March 20, 2010

Letter Issue Date Company Name Issuing Office Subject Close Out Date
March 11, 2010 Toledo, Charles H., M.D. Center for Biologics Evaluation and Research Bioresearch Monitoring Program/IRB April 06, 2010
March 11, 2010 Talisman Limited Baltimore District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Not Issued *
March 10, 2010 NY Fish, Inc. New York District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
March 10, 2010 Clearwater Products, LLC Florida District Office Medical Devices/Adulterated/Misbranded Not Issued *
March 08, 2010 Double B Dairy, LLC Seattle District Office Illegal Drug Residue Not Issued *
March 08, 2010 Frischs Commissary Cincinnati District Office Seafood HACCP/CGMP for Foods/Adulterated
March 08, 2010 Lin, Henry, M.D. Center for Drug Evaluation and Research Clinical Investigator Not Issued *
March 05, 2010 Otologics LLC Center for Devices and Radiological Health Investigational Device Exemptions (Sponsor) Not Issued *
March 04, 2010 Sun Technologies, Inc. Center for Devices and Radiological Health Tanning Facility/Federal Performance Standard for Sunlamp Products/Misbranded Not Issued *
March 02, 2010 Perez-Cruet, Miguelangelo J., M.D., M.S. Center for Devices and Radiological Health Investigational Device Exemptions (Clinical Investigator) Not Issued *


 

Contact FDA

301-796-8490
FDA's Office of Critical Path Programs
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