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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
July 03, 2008 Carematrix, Inc. [ARCHIVED] Chicago District Office CGMP/QSR/Medical Devices/Adulterated N/A *
July 02, 2008 Anika Therapeutics, Inc. [ARCHIVED] New England District Office CGMP/QSR/Medical Devices/Adulterated N/A *
July 02, 2008 Full Circle Dairy, LLC [ARCHIVED] Florida District Office Illegal Drug Residue N/A *
June 30, 2008 Travanti Pharma, Inc. [ARCHIVED] Center for Drug Evaluation and Research Sponsor-Applicant-Monitor-Clinical Research Organization N/A *
June 27, 2008 Oncology Tech, LLP [ARCHIVED] Dallas District Office CGMP/QSR/Medical Devices/Adulterated N/A *
June 27, 2008 Pescaderia Atlantica, Inc. [ARCHIVED] San Juan District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
June 25, 2008 Encore Medical, L.P. [ARCHIVED] New Orleans District Office CGMP/QSR/Medical Devices/Adulterated N/A *
June 25, 2008 Sauflon Pharmaceuticals, LTD [ARCHIVED] Center for Devices and Radiological Health Medical Device Reporting N/A *
June 25, 2008 I.T. Foods Industries Co., LTD. [ARCHIVED] Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated N/A *
June 25, 2008 IOPI Northwest Company, LLC [ARCHIVED] Seattle District Office CGMP/QSR/Medical Devices/Adulterated N/A *
June 25, 2008 Cargill, Inc. [ARCHIVED] Seattle District Office CGMP for Medicated Feeds/Adulterated N/A *
June 24, 2008 Newman Inc., (dba Medi-Stat) [ARCHIVED] New Orleans District Office New Drug/Adulterated/Misbranded N/A *
June 23, 2008 Mathis Ranch, LLC dba Texas Legend Ranch [ARCHIVED] Dallas District Office Illegal Drug Residue N/A *
June 20, 2008 Synapse Biomedical Inc. [ARCHIVED] Center for Devices and Radiological Health Clinical Investigator (Sponsor) N/A *
June 20, 2008 KeyMed (Medical and Industrial Equipment) Ltd. [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated N/A *
June 20, 2008 J & S Dairy Farm Inc. [ARCHIVED] Dallas District Office Illegal Drug Residue N/A *
June 19, 2008 Domina, Gary [ARCHIVED] New England District Office Illegal Drug Residue N/A *
June 19, 2008 Emerson Seafood, Inc. [ARCHIVED] New York District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *
June 19, 2008 Uintah Basin Medical Center [ARCHIVED] Denver District Office CGMP for Blood & Blood Components/Adulterated N/A *
June 19, 2008 Captain Jackie's Seafood, Inc. [ARCHIVED] New Orleans District Office Seafood HACCP/CGMP for Foods/Adulterated N/A *



 

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