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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

Letter Issue Date Company Name Issuing Office Subject Close Out Date
January 25, 2008 Clasen Quality Coatings, Inc. [ARCHIVED] Minneapolis District Office CGMP Deviations N/A *
January 25, 2008 Nature's Way Products, Inc. [ARCHIVED] Denver District Office Dietary Supplements/Food/New Drug/Adulterated/Misbranded N/A *
January 24, 2008 Novartis Vaccines and Diagnostics [ARCHIVED] Center for Biologics Evaluation and Research CGMP Deviations N/A *
January 24, 2008 Medical Action Industries [ARCHIVED] Atlanta District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded N/A *
January 24, 2008 Alfa International Seafood, Inc. & Gamma Seafood Corporation [ARCHIVED] Florida District Office Seafood HACCP N/A *
January 23, 2008 Diagnostic Health Center of Texas, L.P. [ARCHIVED] Dallas District Office Mammography Quality Standards Act N/A *
January 23, 2008 Adams, Mark M.D. [ARCHIVED] Center for Devices and Radiological Health Investigational Device Exemptions N/A *
January 22, 2008 Glen Willow Orchards [ARCHIVED] Philadelphia District Office Juice HACCP N/A *
January 18, 2008 OLMA-XXI Inc [ARCHIVED] New York District Office CGMP for Foods/Seafood HACCP/Adulterated N/A *
January 18, 2008 Replidyne, Inc. [ARCHIVED] Center for Drug Evaluation and Research Sponsor-Applicant-Monitor-Clinical Research Organization N/A *
January 18, 2008 Replidyne, Inc. [ARCHIVED] Center for Drug Evaluation and Research Sponsor-Applicant-Monitor-Clinical Research Organization N/A *
January 18, 2008 Omron Healthcare, Inc. [ARCHIVED] Chicago District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded N/A *
January 17, 2008 Lyne Laboratories, Inc. [ARCHIVED] New England District Office CGMP for Finished Pharmaceuticals/Adulterated N/A *
January 16, 2008 Old Carolina Farms [ARCHIVED] Baltimore District Office Illegal Drug Residue N/A *
January 15, 2008 Hill-Rom, Inc. [ARCHIVED] Detroit District Office CGMP/QSR/Medical Device Reporting/Adulterated/Misbranded N/A *
January 15, 2008 Piedmont Dairy [ARCHIVED] Atlanta District Office Illegal Drug Residue N/A *
January 14, 2008 McLaren Regional Medical Center Institutional Review Board [ARCHIVED] Center for Devices and Radiological Health Institutional Review Board N/A *
January 14, 2008 Tomita Pharmaceutical Co., Ltd [ARCHIVED] Center for Drug Evaluation and Research CGMP/Active Pharmaceutical Ingredients/Adulterated N/A *
January 14, 2008 Bellevue Pharmacy Solution [ARCHIVED] Kansas City District Office Promotional Claims False & Misleading/Misbranded N/A *
January 14, 2008 Baxa Corporation [ARCHIVED] Denver District Office CGMP/QSR/Medical Devices/Adulterated N/A *



 

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ICECI Warning Letters

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