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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

Letter Issue Date Company Name Issuing Office Subject Close Out Date
September 05, 2008 Drs. Foster and Smith, Inc. [ARCHIVED] Minneapolis District Office New Animal Drug/Adulterated N/A *
September 04, 2008 Chloe Foods Corp [ARCHIVED] New York District Office Seafood HACCP/GMP for Foods/Adulterated N/A *
September 04, 2008 Magnificent Medical Equipment, Inc. (dba Tony Riso Company) [ARCHIVED] Florida District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded N/A *
September 04, 2008 Lifestyle GP Company, LLC [ARCHIVED] Florida District Office CGMP/QSR/Medical Devices/Adulterated N/A *
September 03, 2008 Bayer Health Care LLC [ARCHIVED] Center for Veterinary Medicine Promotional Claims/False & Misleading/Misbranded N/A *
September 03, 2008 Shrock, John E. [ARCHIVED] Cincinnati District Office Illegal Drug Residue N/A *
September 03, 2008 Gardiziola, Gregory, D.O. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator N/A *
September 03, 2008 Cuisine Solutions, Inc. [ARCHIVED] Baltimore District Office Seafood HACCP/Adulterated N/A *
September 03, 2008 Galveston Shrimp & Fish Company, Inc. [ARCHIVED] Dallas District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
September 02, 2008 Avole, Inc. [ARCHIVED] San Juan District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
September 02, 2008 Packers Provisions Co. of PR [ARCHIVED] San Juan District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
September 02, 2008 Roselife, LLC [ARCHIVED] Detroit District Office CGMP Requirement for Food Manufacturing/Adulterated N/A *
September 02, 2008 Whitney Labs [ARCHIVED] Florida District Office CGMP for Finished Pharmaceuticals/Deviations/Adulterated N/A *
September 02, 2008 Hamilton Medical Center [ARCHIVED] Center for Devices and Radiological Health Institutional Review Board (IRB) N/A *
September 02, 2008 Jerusalem Manufacturing Nature Foods & Wholesalers, Inc. [ARCHIVED] Detroit District Office Food Labeling/False & Misleading Claims/Adulterated/Misbranded N/A *
September 01, 2008 Viacres L.L.L. and Natural Milk L.L.C. [ARCHIVED] Seattle District Office Illegal Drug Residue N/A *
September 01, 2008 Concept Laboratories, Inc. [ARCHIVED] Chicago District Office CGMP for Finished Pharmaceuticals/Deviations/Adulterated N/A *
August 29, 2008 KeraCure, Inc. [ARCHIVED] Center for Devices and Radiological Health Institutional Review Board (IRB) N/A *
August 29, 2008 VL Livestock Company, Inc. [ARCHIVED] Seattle District Office Illegal Drug Residue N/A *
August 28, 2008 LSG Sky Chefs [ARCHIVED] New England District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *



 

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