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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
01/23/2008 Diagnostic Health Center of Texas, L.P. [ARCHIVED] Dallas District Office Mammography Quality Standards Act N/A *
01/22/2008 Glen Willow Orchards [ARCHIVED] Philadelphia District Office Juice HACCP N/A *
01/18/2008 Omron Healthcare, Inc. [ARCHIVED] Chicago District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded N/A *
01/18/2008 OLMA-XXI Inc [ARCHIVED] New York District Office CGMP for Foods/Seafood HACCP/Adulterated N/A *
01/18/2008 Replidyne, Inc. [ARCHIVED] Center for Drug Evaluation and Research Sponsor/Monitor/Contract Research Organization N/A *
01/17/2008 Lyne Laboratories, Inc. [ARCHIVED] New England District Office CGMP for Finished Pharmaceuticals/Adulterated N/A *
01/16/2008 Old Carolina Farms [ARCHIVED] Baltimore District Office Illegal Drug Residue N/A *
01/15/2008 Piedmont Dairy [ARCHIVED] Atlanta District Office Illegal Drug Residue 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 *
01/14/2008 Baxa Corporation [ARCHIVED] Denver District Office CGMP/QSR/Medical Devices/Adulterated N/A *
01/14/2008 Bellevue Pharmacy Solution [ARCHIVED] Kansas City District Office Promotional Claims False & Misleading/Misbranded N/A *
01/11/2008 Papas Dairy, LLC [ARCHIVED] New York District Office Illegal Drug Residue N/A *
01/10/2008 American Hormones, Inc. [ARCHIVED] New York District Office New Drug/Adulterated/Misbranded N/A *
01/09/2008 Land Ice and Fish Limited [ARCHIVED] Center for Food Safety and Applied Nutrition Seafood HACCP/Adulterated N/A *
01/09/2008 Rai, Ansaar T., M.D. [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator N/A *
01/09/2008 Trinidad Dock & Fishing Services Ltd [ARCHIVED] Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated N/A *
01/08/2008 Wilbur Ellis Company [ARCHIVED] Seattle District Office CGMP for Medicated Feeds/Adulterated 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 Panorama Compounding Pharmacy [ARCHIVED] Los Angeles 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 *
01/07/2008 Delicias de Espana, Inc. [ARCHIVED] Florida District Office Seafood HACCP/Insanitary Conditions/Adulterated N/A *
01/07/2008 Saint John's Medical Plaza Pharmacy [ARCHIVED] Los Angeles District Office New Drug/False Misleading/Labeling/Misbranded N/A *
01/07/2008 Global Protection Corp. [ARCHIVED] New England District Office CGMP/QSR/Medical Device Reporting/Adulterated 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 ConnexMD, Inc. [ARCHIVED] Seattle District Office CGMP/QSR/Medical Device Reporting/Adulterated/Misbranded N/A *
01/03/2008 Superior Products, Inc. [ARCHIVED] Cincinnati District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/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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