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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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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

Posted on May 29, 2009

Letter Issue Date Company Name Issuing Office Subject Close Out Date
October 23, 2008 Jerome Stevens Pharmaceuticals, Inc New York District Office CGMP for Finished Pharmaceuticals/Adulterated N/A *
October 22, 2008 Sleeping Bear Apiaries Detroit District Office Promotional Claims/False & Misleading/Misbranded N/A *
October 22, 2008 Maria's Fresh Seafood Market, L.L.C. Florida District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
October 22, 2008 Miller, Andrew J. Cincinnati District Office Illegal Drug Residue N/A *
October 22, 2008 Red Arrow Dairy, LLC Detroit District Office Illegal Drug Residue N/A *
October 21, 2008 Power Medical Interventions Incorporation Philadelphia District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded N/A *
October 21, 2008 Paul Rothermel Livestock Cincinnati District Office Illegal Drug Residue N/A *
October 21, 2008 Omega Tech Labs., LLC Seattle District Office CGMP for Finished Pharmaceuticals/Misbranded/Adulterated N/A *
October 21, 2008 NHS Clarkson West Medical Center Dallas District Office Mammography Quality Standards Act N/A *
October 17, 2008 Kayline Inc. New Orleans District Office CGMP/QSR/Medical Devices/Adulterated N/A *
October 17, 2008 Diapro, Inc. (dba Diapro USA Inc) San Francisco District Office Diapro, Inc. (dba Diapro USA Inc), San Francisco District Office, Natural PentosePlus N/A *
October 17, 2008 Steritec Products, Inc. Denver District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated N/A *
October 16, 2008 Supreme Seafood, LLC Denver District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
October 16, 2008 BJ Packers Inc. San Juan District Office Seafood HACCP/Food Labeling/Adulterated/Misbranded N/A *
October 16, 2008 BioMedix Vascular Solutions, Inc. Minneapolis District Office CGMP/QSR/Medical Devices/Adulterated N/A *
October 15, 2008 Valley Springs Artesian Gold LLC Minneapolis District Office Bottled Drinking Water N/A *
October 10, 2008 Hull Veterinary Clinic, PC Kansas City District Office Illegal Drug Residue N/A *
October 10, 2008 LifeCell Corporation CGMP/QSR/Medical Devices/Adulterated N/A *
October 09, 2008 Blessing Inc. (DBA Blessing Seafood) Dallas District Office Seafood HACCP/Adulterated N/A *
October 09, 2008 Natural Biology, Inc. Atlanta District Office New Drug/Labeling/False & Misleading Claims/Misbranded N/A *


 

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ICECI Warning Letters

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Food and Drug Administration

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Rockville, MD 20857
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