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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
10/29/2008 Aerosol Science Laboratories Inc. [ARCHIVED] Center for Drug Evaluation and Research False & Misleading Claims/New Drug/Misbranded N/A *
10/28/2008 BioSafe America Corporation [ARCHIVED] Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded N/A *
10/27/2008 Bayer HealthCare LLC [ARCHIVED] Center for Drug Evaluation and Research Drug Labeling/Promotional Claims/Misbranded N/A *
10/27/2008 Bayer HealthCare LLC [ARCHIVED] Center for Drug Evaluation and Research Drug Labeling/Promotional Claims/Misbranded N/A *
10/24/2008 IBA Molecular, Inc [ARCHIVED] Baltimore District Office Deviation/Adulterated N/A *
10/23/2008 P East Trading Corporation [ARCHIVED] New York District Office Seafood HACCP/Adulterated N/A *
10/23/2008 Jerome Stevens Pharmaceuticals, Inc [ARCHIVED] New York District Office CGMP for Finished Pharmaceuticals/Adulterated N/A *
10/22/2008 Red Arrow Dairy, LLC [ARCHIVED] Detroit District Office Illegal Drug Residue N/A *
10/22/2008 Maria's Fresh Seafood Market, L.L.C. [ARCHIVED] Florida District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
10/22/2008 Sleeping Bear Apiaries [ARCHIVED] Detroit District Office Promotional Claims/False & Misleading/Misbranded N/A *
10/22/2008 Miller, Andrew J. [ARCHIVED] Cincinnati District Office Illegal Drug Residue N/A *
10/21/2008 Paul Rothermel Livestock [ARCHIVED] Cincinnati District Office Illegal Drug Residue N/A *
10/21/2008 NHS Clarkson West Medical Center [ARCHIVED] Dallas District Office Mammography Quality Standards Act N/A *
10/21/2008 Omega Tech Labs., LLC [ARCHIVED] Seattle District Office CGMP for Finished Pharmaceuticals/Misbranded/Adulterated N/A *
10/21/2008 Power Medical Interventions Incorporation [ARCHIVED] Philadelphia District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded N/A *
10/17/2008 Diapro, Inc. (dba Diapro USA Inc) [ARCHIVED] San Francisco District Office Diapro, Inc. (dba Diapro USA Inc), San Francisco District Office, Natural PentosePlus N/A *
10/17/2008 Steritec Products, Inc. [ARCHIVED] Denver District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated N/A *
10/17/2008 Kayline Inc. [ARCHIVED] New Orleans District Office CGMP/QSR/Medical Devices/Adulterated N/A *
10/16/2008 BioMedix Vascular Solutions, Inc. [ARCHIVED] Minneapolis District Office CGMP/QSR/Medical Devices/Adulterated N/A *
10/16/2008 BJ Packers Inc. [ARCHIVED] San Juan District Office Seafood HACCP/Food Labeling/Adulterated/Misbranded N/A *
10/16/2008 Supreme Seafood, LLC [ARCHIVED] Denver District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
10/15/2008 Valley Springs Artesian Gold LLC [ARCHIVED] Minneapolis District Office Bottled Drinking Water N/A *
10/10/2008 LifeCell Corporation [ARCHIVED] CGMP/QSR/Medical Devices/Adulterated N/A *
10/10/2008 Hull Veterinary Clinic, PC [ARCHIVED] Kansas City District Office Illegal Drug Residue N/A *
10/09/2008 Richards, Douglas L. [ARCHIVED] New York District Office Illegal Drug Residue N/A *
10/09/2008 Jarrett Fertility Group, LLC [ARCHIVED] Detroit District Office Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products N/A *
10/09/2008 Legacy Dairy Farms LP [ARCHIVED] Dallas District Office Illegal Drug Residue N/A *
10/09/2008 Natural Biology, Inc. [ARCHIVED] Atlanta District Office New Drug/Labeling/False & Misleading Claims/Misbranded N/A *
10/09/2008 Center for Fertility and Gynecology [ARCHIVED] Los Angeles District Office Human Cells, Tissues & Cellular Products N/A *
10/09/2008 Blessing Inc. (DBA Blessing Seafood) [ARCHIVED] Dallas District Office Seafood HACCP/Adulterated N/A *
10/08/2008 Mackinac Straits Fish Company, inc. [ARCHIVED] Detroit District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
10/08/2008 Citra Mina Seafood Corporation [ARCHIVED] Center for Food Safety and Applied Nutrition Seafood HACCP/Adulterated N/A *
10/08/2008 Organizaciion Agricultores Bo. Espino [ARCHIVED] San Juan District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
10/07/2008 F.B. Indian Ridge Dairy [ARCHIVED] Dallas District Office Illegal Drug Residue N/A *
10/07/2008 Town of Bucksport [ARCHIVED] New England District Office PHS Act/Violation N/A *
10/06/2008 Lisanby, Sarah H., M.D. [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator N/A *
10/02/2008 Madespa S.A. [ARCHIVED] Center for Devices and Radiological Health CGMP Requirements for Medical Devices/Quality System Regulations/Adulterated N/A *
10/01/2008 Holub, Richard, MD [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator N/A *
09/30/2008 Pure Prescriptions Inc. [ARCHIVED] Los Angeles District Office New Drugs N/A *
09/30/2008 Neuro Kinetics, Inc. [ARCHIVED] Philadelphia District Office Premarket Approval/Misbranded/Adulterated N/A *
09/30/2008 Wellmont Holston Valley Medical Center [ARCHIVED] Center for Devices and Radiological Health Institutional Review Board (IRB) N/A *
09/29/2008 Lehman's Egg Service Inc. [ARCHIVED] Philadelphia District Office Acidified Foods/Emergency Permit Control/Adulterated/Misbranded N/A *
09/29/2008 Laboratory Corporation of America [ARCHIVED] Center for Devices and Radiological Health Device Lacks Marketing Clearance Approval/Adulterated/Misbranded N/A *
09/26/2008 Alpine Oral Care, LLC [ARCHIVED] Dallas District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded N/A *
09/25/2008 Renewal Research [ARCHIVED] San Francisco District Office Promotional Claims False & Misleading Adulterated/Misbranded N/A *
09/25/2008 Mallinckrodt Inc. [ARCHIVED] Center for Drug Evaluation and Research DDMAC/Promotional Claims False & Misleading/Misbranded N/A *
09/25/2008 Johnson & Johnson Pharmaceutical Research and Development, L.L.C. [ARCHIVED] Center for Drug Evaluation and Research DDMAC/Promotional Claims False & Misleading/Misbranded N/A *
09/25/2008 Steris Corporation [ARCHIVED] New England District Office CGMP/QSR/Medical Devices/Adulterated N/A *
09/25/2008 Novartis Pharmaceuticals Corp [ARCHIVED] Center for Drug Evaluation and Research DDMAC/Promotional Claims False & Misleading/Misbranded N/A *
09/25/2008 Trident Seafoods, Inc. [ARCHIVED] Seattle District Office Seafood HACCP/GMP for Foods/Adulterated N/A *

 

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