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U.S. Department of Health and Human Services

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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
02/21/2008 InnoMed Technologies, Inc. and RespCare, Inc. [ARCHIVED] Florida District Office CGMP/QSR/Medical Devices/Adulterated N/A *
02/19/2008 SyntheMed Inc [ARCHIVED] Center for Devices and Radiological Health Sponsor/Monitor/Contract Research Organization N/A *
02/12/2008 Michael S. Miller, D.O. [ARCHIVED] Center for Biologics Evaluation and Research Clinical Investigator - Human Trials N/A *
02/04/2008 MedX Corporation [ARCHIVED] Florida District Office CGMP/QSR/Medical Devices/Adulterated N/A *
02/01/2008 Vintage Pharmaceuticals, LLC [ARCHIVED] New Orleans District Office CGMP/Adulterated N/A *
01/31/2008 Gulla, Jennifer [ARCHIVED] Los Angeles District Office Street Drugs Alternative N/A *
01/30/2008 A-Solutions, Inc. [ARCHIVED] Cincinnati District Office CGMP for Medical Devices/QS/Adulterated N/A *
01/30/2008 Katzen, Barry M.D. [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator - Human Trials N/A *
01/28/2008 Kollef, Marin H., MD [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator - Human Trials N/A *
01/28/2008 Siemens Medical Solutions USA, Inc. [ARCHIVED] New Orleans District Office CGMP/QSR/Medical Devices/Adulterated N/A *
01/25/2008 Clasen Quality Coatings, Inc. [ARCHIVED] Minneapolis District Office CGMP Deviations N/A *
01/25/2008 Nature's Way Products, Inc. [ARCHIVED] Denver District Office Dietary Supplements/Food/New Drug/Adulterated/Misbranded N/A *
01/24/2008 Alfa International Seafood, Inc. & Gamma Seafood Corporation [ARCHIVED] Florida District Office Seafood HACCP N/A *
01/24/2008 Novartis Vaccines and Diagnostics [ARCHIVED] Center for Biologics Evaluation and Research CGMP Deviations N/A *
01/23/2008 Adams, Mark M.D. [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator - Human Trials N/A *
01/18/2008 Omron Healthcare, Inc. [ARCHIVED] Chicago District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded N/A *
01/17/2008 Lyne Laboratories, Inc. [ARCHIVED] New England District Office CGMP for Finished Pharmaceuticals/Adulterated N/A *
01/15/2008 Hill-Rom, Inc. [ARCHIVED] Detroit District Office CGMP/QSR/Medical Device Reporting/Adulterated/Misbranded N/A *
01/14/2008 Tomita Pharmaceutical Co., Ltd [ARCHIVED] Center for Drug Evaluation and Research CGMP/Active Pharmaceutical Ingredients/Adulterated N/A *
01/10/2008 American Hormones, Inc. [ARCHIVED] New York District Office New Drug/Adulterated/Misbranded N/A *
01/07/2008 Pharmacy Compounding Specialties [ARCHIVED] Dallas District Office New Drug/False Misleading/Labeling/Misbranded N/A *
01/07/2008 Murray Avenue Apothecary [ARCHIVED] Philadelphia District Office New Drug/False Misleading/Labeling/Misbranded N/A *
01/07/2008 Pacifica Pharmacy [ARCHIVED] Los Angeles District Office New Drug/False Misleading/Labeling/Misbranded N/A *
01/07/2008 Village Compounding Pharmacy [ARCHIVED] Dallas District Office New Drug/False Misleading/Labeling/Misbranded N/A *
01/07/2008 Reed's Compounding Pharmacy [ARCHIVED] Los Angeles District Office New Drug/False Misleading/Labeling/Misbranded N/A *
01/04/2008 Noven Pharmaceuticals, Inc. [ARCHIVED] Florida District Office CGMP for Drugs/Manufacture, Processing, Packing, Holding/Adulterated N/A *
01/03/2008 Amico Laboratories, Inc. [ARCHIVED] New Orleans District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded N/A *
01/03/2008 Care Tech Industries, Inc. [ARCHIVED] Florida District Office Premarket Approval/Misbranded/Adulterated N/A *

 

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ICECI Warning Letters

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