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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

 
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Letter Issue Date Company Name Issuing Office Subject Close Out Date
September 25, 2008 Forest Laboratories Inc. [ARCHIVED] Center for Drug Evaluation and Research DDMAC/Promotional Claims False & Misleading/Misbranded N/A *
September 24, 2008 C Change Surgical, LLC [ARCHIVED] Atlanta District Office CGMP/QSR/Medical Devices/Adulterated N/A *
September 24, 2008 Fulton Seafood Inc [ARCHIVED] Dallas District Office Seafood HACCP/Adulterated N/A *
September 23, 2008 Pharmalucence, Inc. [ARCHIVED] New England District Office CGMP for Finished Pharmaceuticals/Deviations/Adulterated N/A *
September 19, 2008 Meek's Seafood, Inc. [ARCHIVED] New Orleans District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
September 18, 2008 Swiss American Products, Inc. [ARCHIVED] Dallas District Office CGMP/QSR/Medical Devices/Adulterated N/A *
September 17, 2008 Technomed Europe [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated N/A *
September 17, 2008 Omega Supply [ARCHIVED] Los Angeles District Office New Drug/Labeling/False & Misleading Claims N/A *
September 16, 2008 Ranbaxy Laboratories, Ltd., Paonta Sahib, India [ARCHIVED] Center for Drug Evaluation and Research CGMP/Drug/Deviations/Adulterated N/A *
September 16, 2008 Ranbaxy Laboratories, Ltd., Dewas, India [ARCHIVED] Center for Drug Evaluation and Research CGMP/Drug/Deviations/Adulterated N/A *
September 15, 2008 Airsep Corporation [ARCHIVED] New York District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded N/A *
September 11, 2008 A1 Discount Vitamins [ARCHIVED] Dallas District Office DDMAC/Promotional Claims False & Misleading/Misbranded N/A *
September 10, 2008 Stratec Medizintechnik Gmbh [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated N/A *
September 10, 2008 San Mar Manufacturing Corporation [ARCHIVED] San Juan District Office Food Labeling/False & Misleading Claims/Misbranded N/A *
September 05, 2008 Biosafe Laboratories [ARCHIVED] Chicago District Office CGMP/QSR/Medical Devices/Adulterated N/A *
September 05, 2008 White, Rodney A., M.D. [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator N/A *
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 Sponsor/Monitor/Contract Research Organization 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 *
August 28, 2008 Koike Seafood, Inc. [ARCHIVED] Seattle District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
August 27, 2008 Sgarlato Laboratories [ARCHIVED] San Francisco District Office CGMP/QSR/Medical Devices/Adulterated N/A *
August 27, 2008 Fall Prevention Technologies [ARCHIVED] Cincinnati District Office CGMP/QSR/Medical Devices/Adulterated N/A *
August 27, 2008 Ziran, Bruce H., MD [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator N/A *
August 25, 2008 Ovation Pharmaceuticals, Inc. [ARCHIVED] Center for Biologics Evaluation and Research Promotional Claims/False & Misleading/Misbranded N/A *
August 25, 2008 A. Tarantino and Sons, Inc. [ARCHIVED] San Francisco District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
August 22, 2008 Health Center for Better Living, Inc. [ARCHIVED] Florida District Office New Drug/Labeling/False & Misleading Claims N/A *
August 21, 2008 SeniorLife Health Inc. [ARCHIVED] Los Angeles District Office New Drug/Misbranded N/A *
August 21, 2008 Brede, Inc. [ARCHIVED] Detroit District Office CGMP/Deviations For Food Manufacturers/Adulterated N/A *
August 21, 2008 SeniorLife Health Inc. [ARCHIVED] Los Angeles District Office New Drug/Labeling/False & Misleading Claims N/A *
August 20, 2008 Suarez Corporation Industries, Inc. [ARCHIVED] Cincinnati District Office Premarket Approval/Misbranded/Adulterated N/A *
August 19, 2008 ONBO Electronics Company Ltd [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated N/A *
August 19, 2008 AliMed Corporation [ARCHIVED] New England District Office CGMP/QSR/Medical Devices/Adulterated N/A *
August 19, 2008 Mission Mountain Food Enterprise Center [ARCHIVED] Seattle District Office Acidified Foods/Adulterated N/A *

 

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