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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2006 Warning Letters

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Tobacco Retailer Warning Letters

 

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Warning Letters issued in 2006

 

* 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
January 12, 2006 Empresas Y-nuina Inc. [ARCHIVED] San Juan District Office Seafood HACCP/Adulterated N/A *
January 12, 2006 PuraVida Health Inc. [ARCHIVED] Denver District Office Labeling/Promotional Claims False & Misleading/New Drug/Misbranded N/A *
January 11, 2006 Western Fish Company, Inc. [ARCHIVED] Los Angeles District Office CGMP for Foods/Seafood HACCP/Adulterated N/A *
January 10, 2006 CareFore Medical Incorporated [ARCHIVED] Kansas City District Office CGMP/QSR/Medical Device Reporting/Adulterated N/A *
January 09, 2006 Prodesse, Inc. [ARCHIVED] Center for Devices and Radiological Health Lacks Premarket Approval Application/Adulterated N/A *
January 08, 2006 Trim International, Inc. [ARCHIVED] Florida District Office Labeling/Promotional Claims False & Misleading/New Drug/Misbranded N/A *
January 05, 2006 Gambro Dasco S.p.a. [ARCHIVED] Center for Devices and Radiological Health Current Good Manufacturing Practice Regulation/Adulterated N/A *
January 05, 2006 Haemacure Corporation [ARCHIVED] Florida District Office QSR For Medical Device/Adulterated N/A *
January 03, 2006 Theken Spine LLC [ARCHIVED] Cincinnati District Office Quality System Regulatory Adulterated/Misbranded N/A *



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Contact FDA

ICECI Warning Letters

Division of Freedom of Information (HFI-35)

Food and Drug Administration

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