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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

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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

 

Posted on February 02, 2009

Letter Issue Date Company Name Issuing Office Subject Close Out Date
December 28, 2006 Thomas Crab Company Florida District Office Seafood HACCP/Adulterated N/A *
December 27, 2006 Applied Water Engineering, Inc. Denver District Office CGMP/QSR/Medical Device Reporting/Adulterated N/A *
December 27, 2006 Tienda, Inc Baltimore District Office Seafood HACCP/Adulterated N/A *
December 27, 2006 Rickland Farms, LLC Minneapolis District Office Animals for sale for slaughter/Adulterated N/A *
December 26, 2006 Abraxis Bioscience, Inc. Chicago District Office Deviations from CGMP for Finished Pharmaceuticals N/A *
December 26, 2006 Lee Laboratories, Inc. Dallas District Office CGMP Requirements of the Quality System Regulations/Adulterated N/A *
December 21, 2006 Colusa Regional Medical Center San Francisco District Office Mammography Quality Standards N/A *
December 21, 2006 Palmer Farms New England District Office Animals for sale for slaughter/Adulterated N/A *
December 21, 2006 Sam's Homemade Cheesecake Inc. Los Angeles District Office CGMP Regulation For Food/Adulterated N/A *
December 20, 2006 TMJ Implants, Inc. Center for Devices and Radiological Health Lacks Premarket Approval Application/Adulterated/Misbranded N/A *
December 20, 2006 Sharma, Baljit K., M.D. Center for Devices and Radiological Health Clinical Investigator N/A *
December 20, 2006 Williams Farms Inc. New England District Office Animals for sale for slaughter/Adulterated N/A *
December 18, 2006 Biora AB Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated N/A *
December 18, 2006 FUZE Beverages, LLC New Jersey District Office CGMP/Food Labeling/New Drug N/A *
December 15, 2006 Kingmar Seafood Corporation Florida District Office Seafood HACCP/Adulterated N/A *
December 12, 2006 GSCM Ventures Inc. San Francisco District Office Labeling/Promotional Claims False & Misleading/New Drug/Misbranded N/A *
December 12, 2006 LCDG Enterprise San Francisco District Office Seafood HACCP/Adulterated N/A *
December 12, 2006 Viasys Healthcare Cincinnati District Office CGMP/Requirements for Medical Devices/QSR/Adulterated N/A *
December 08, 2006 Schumacher's New York District Office Illegal Drug Residue N/A *
December 08, 2006 Quick-Fill Mobile Oxygen, Inc. New Orleans District Office CGMP for Finished Pharmaceuticals/Adulterated N/A *


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Contact FDA

ICECI Warning Letters

Division of Freedom of Information (HFI-35)

Food and Drug Administration

5600 Fishers Lane

Rockville, MD 20857
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