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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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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 08, 2006 Nasiff Associates, Inc. New York District Office CGMP/Adulterated N/A *
December 08, 2006 Ganeden Biotech Inc. Cincinnati District Office Misbranded/Labeling/Unauthorized Health Claims N/A *
December 08, 2006 MRL Inc. Chicago District Office CGMP For Medical Device Report/Adulterated N/A *
December 08, 2006 Ratcliff, David C, M.D. Center for Devices and Radiological Health Institutional Review Board (IRB) N/A *
December 08, 2006 Biotecx Laboratories, Inc. Dallas District Office CGMP/QSR/Medical Device Reporting/Adulterated N/A *
December 06, 2006 INCELL Corporation, LLC Center for Biologics Evaluation and Research GLP/Bioresearch Monitoring Program/Investigational drugs N/A *
December 04, 2006 Ritch, Robert M.D. Center for Devices and Radiological Health Clinical Investigator N/A *
December 04, 2006 New England Compounding Center New England District Office Pharmacy Compounding/New Drug/Misbranded N/A *
December 04, 2006 University Pharmacy Denver District Office Pharmacy Compounding/New Drug/Misbranded N/A *
December 04, 2006 Customs Scripts Pharmacy Florida District Office Pharmacy Compounding/New Drug/Misbranded N/A *
December 04, 2006 Triangle Compounding Pharmacy Atlanta District Office Pharmacy Compounding/New Drug/Misbranded N/A *
December 04, 2006 Hal's Compounding Pharmacy, Inc Center for Drug Evaluation and Research Pharmacy Compounding/New Drug/Misbranded N/A *
December 04, 2006 Feenstra, John Seattle District Office Illegal Drug Residue N/A *
December 04, 2006 Ritch, Robert MD Center for Devices and Radiological Health Clinical Investigator N/A *
December 04, 2006 Lamb Farms, Inc. New York District Office Illegal Drug Residue N/A *
December 01, 2006 Spoonamore Drug Co., Inc. Cincinnati District Office Pharmacy Compounding/New Drug/Adulterated/Misbranded N/A *
November 30, 2006 C.R.D. Group, Inc. Florida District Office Seafood HACCP/Adulterated N/A *
November 29, 2006 Skytron Detroit District Office Current Good Manufacturing Requirements for Medical Devices/Adulterated N/A *
November 29, 2006 Steris Corporation New Orleans District Office Medical Device Reporting (MDR) Regulation Misbranded/Adulterated N/A *
November 29, 2006 HemoSense, Inc. San Francisco District Office CGMP for Medical Devices/QS/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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