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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
12/30/2008 Dongkuk Techco Rubber Ind. Sdn Bhd [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Adulterated N/A *
12/24/2008 Aunt Kitty's Foods, Inc. [ARCHIVED] New Jersey District Office Food Labeling Misbranded N/A *
12/22/2008 Newman's Own Organics Center for Food Safety and Applied Nutrition N/A *
12/22/2008 Columbia Presbyterian Medical Center [ARCHIVED] New York District Office Deviation/Adulterated N/A *
12/22/2008 I-Flow Corporation [ARCHIVED] Los Angeles District Office CGMP/QSR/Medical Devices/Adulterated N/A *
12/16/2008 Civic Center Pharmacy [ARCHIVED] Los Angeles District Office New Drug, Unapproved N/A *
12/15/2008 Craig General Hospital [ARCHIVED] Dallas District Office Deviation from Good Manufacturing Practice N/A *
12/10/2008 Coca-Cola Company (The) [ARCHIVED] Center for Food Safety and Applied Nutrition Labeling/False & Misleading Claims/Adulterated/Misbranded N/A *
12/10/2008 Virbac Inc. [ARCHIVED] Kansas City District Office CGMP For Manufacturing, Packing, Storage or Installation/Adulterated/Misbranded N/A *
12/04/2008 Haemonetics Corporation [ARCHIVED] Chicago District Office CGMP/QSR/Medical Devices/Adulterated N/A *
12/01/2008 Perich, Larry M [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator N/A *
11/20/2008 Contract Medical Manufacturing [ARCHIVED] New England District Office CGMP/QSR/Medical Devices/Adulterated N/A *
11/19/2008 Bernhard's Bakery, Inc. [ARCHIVED] Cincinnati District Office CGMP in Manufacturing, Packing, or Holding Human Food/Adulterated N/A *
11/19/2008 Goosefoot Acres, Inc. [ARCHIVED] Cincinnati District Office Labeling/False & Misleading Claims/New Drug/Misbranded N/A *
11/18/2008 RHG & Company, Inc., dba Vital Nutrients [ARCHIVED] New England District Office New Drug/Labeling/False & Misleading Claims/Misbranded N/A *
11/17/2008 Dabruzzi's Italian Foods, Inc. [ARCHIVED] Minneapolis District Office Food Labeling/False & Misleading/Misbranded N/A *
11/13/2008 Rezai, Ali R, M.D [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator N/A *
11/12/2008 Steven's Pharmacy [ARCHIVED] Los Angeles District Office New Drug/Labeling/False & Misleading Claims N/A *
10/31/2008 Three Sister's Snacks Corporation [ARCHIVED] Minneapolis District Office Nutrition Labeling of Food/Misbranded N/A *
10/31/2008 Caraco Pharmaceutical Laboratories, Ltd [ARCHIVED] Detroit District Office CGMP Deviations N/A *
10/31/2008 Deltex Pharmaceuticals Inc [ARCHIVED] Dallas District Office CGMP For Drugs/Manufacture, Processing, Packing, Holding/Adulterated/Misbranded N/A *
10/29/2008 Aerosol Science Laboratories Inc. [ARCHIVED] Center for Drug Evaluation and Research False & Misleading Claims/New Drug/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 *
10/22/2008 Red Arrow Dairy, LLC [ARCHIVED] Detroit District Office Illegal Drug Residue N/A *
10/22/2008 Sleeping Bear Apiaries [ARCHIVED] Detroit District Office Promotional Claims/False & Misleading/Misbranded N/A *
10/21/2008 Omega Tech Labs., LLC [ARCHIVED] Seattle District Office CGMP for Finished Pharmaceuticals/Misbranded/Adulterated N/A *
10/16/2008 BioMedix Vascular Solutions, Inc. [ARCHIVED] Minneapolis District Office CGMP/QSR/Medical Devices/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 *
10/09/2008 Natural Biology, Inc. [ARCHIVED] Atlanta District Office New Drug/Labeling/False & Misleading Claims/Misbranded N/A *
10/09/2008 Blessing Inc. (DBA Blessing Seafood) [ARCHIVED] Dallas District Office Seafood HACCP/Adulterated N/A *
10/06/2008 Lisanby, Sarah H., M.D. [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator 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 *
09/29/2008 Laboratory Corporation of America [ARCHIVED] Center for Devices and Radiological Health Device Lacks Marketing Clearance Approval/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 Novartis Pharmaceuticals Corp [ARCHIVED] Center for Drug Evaluation and Research DDMAC/Promotional Claims False & Misleading/Misbranded N/A *
09/25/2008 Forest Laboratories Inc. [ARCHIVED] Center for Drug Evaluation and Research DDMAC/Promotional Claims False & Misleading/Misbranded N/A *
09/23/2008 Pharmalucence, Inc. [ARCHIVED] New England District Office CGMP for Finished Pharmaceuticals/Deviations/Adulterated N/A *
09/18/2008 Swiss American Products, Inc. [ARCHIVED] Dallas District Office CGMP/QSR/Medical Devices/Adulterated N/A *
09/16/2008 Ranbaxy Laboratories, Ltd., Paonta Sahib, India [ARCHIVED] Center for Drug Evaluation and Research CGMP/Drug/Deviations/Adulterated N/A *
09/16/2008 Ranbaxy Laboratories, Ltd., Dewas, India [ARCHIVED] Center for Drug Evaluation and Research CGMP/Drug/Deviations/Adulterated N/A *
09/11/2008 A1 Discount Vitamins [ARCHIVED] Dallas District Office DDMAC/Promotional Claims False & Misleading/Misbranded N/A *
09/05/2008 Biosafe Laboratories [ARCHIVED] Chicago District Office CGMP/QSR/Medical Devices/Adulterated N/A *
09/05/2008 Drs. Foster and Smith, Inc. [ARCHIVED] Minneapolis District Office New Animal Drug/Adulterated N/A *
09/03/2008 Bayer Health Care LLC [ARCHIVED] Center for Veterinary Medicine Promotional Claims/False & Misleading/Misbranded N/A *
09/02/2008 Whitney Labs [ARCHIVED] Florida District Office CGMP for Finished Pharmaceuticals/Deviations/Adulterated N/A *

 

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ICECI Warning Letters

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