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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2002 Warning Letters

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Warning Letters for 2002

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* 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
October 11, 2002 Amide Pharmaceutical Inc. [ARCHIVED] Center for Drug Evaluation and Research Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin N/A *
October 11, 2002 Mutual Pharmaceutical Co Inc. [ARCHIVED] Center for Drug Evaluation and Research Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin N/A *
October 11, 2002 Major Pharmaceuticals Inc. [ARCHIVED] Center for Drug Evaluation and Research Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin N/A *
October 11, 2002 Eckerd Drug Co [ARCHIVED] Center for Drug Evaluation and Research Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin N/A *
October 11, 2002 Capellon Pharmaceuticals Inc. [ARCHIVED] Center for Drug Evaluation and Research Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin N/A *
October 11, 2002 Iopharm Laboratories Inc. [ARCHIVED] Center for Drug Evaluation and Research Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin N/A *
October 11, 2002 Thrift Drug Services [ARCHIVED] Center for Drug Evaluation and Research Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin N/A *
October 11, 2002 Murfreesboro Pharmaceutical Nursing Supply [ARCHIVED] Center for Drug Evaluation and Research Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin N/A *
October 11, 2002 M G Acquistion LLC [ARCHIVED] Center for Drug Evaluation and Research Certain Drugs Accorded New Drug Status through Rulemaking Procedures/Guaifenesin N/A *
October 11, 2002 Keil Pharmaceuticals Inc. [ARCHIVED] Center for Drug Evaluation and Research Certain Drugs Accorded New Drug Status through Rulemaking Procedures/Guaifenesin N/A *
October 11, 2002 Biovail Pharmaceuticals Inc. [ARCHIVED] Center for Drug Evaluation and Research Certain Drugs Accorded New Drug Status through Rulemaking Procedures/Guaifenesin N/A *
October 11, 2002 Sovereign Pharmaceutical Inc. [ARCHIVED] Center for Drug Evaluation and Research Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin N/A *
October 11, 2002 ST International Inc. [ARCHIVED] Center for Drug Evaluation and Research Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin N/A *
October 11, 2002 Ivax Laboratories [ARCHIVED] Center for Drug Evaluation and Research Certain Drugs Accorded New Drug Status through Rulemaking Procedures/Guaifenesin N/A *
October 11, 2002 Corepharma LLC [ARCHIVED] Center for Drug Evaluation and Research Certain Drugs Accorded New Drug Status through Rulemaking Procedures/Guaifenesin N/A *
October 11, 2002 Amerisource Health Services Corp. [ARCHIVED] Center for Drug Evaluation and Research Certain Drugs Accorded New Drug Status through Rulemaking Procedures/Guaifenesin N/A *
October 11, 2002 MCR American Phamaceuticals Inc. [ARCHIVED] Center for Drug Evaluation and Research Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin N/A *
October 11, 2002 Qualitest Pharmaceuticals Inc. [ARCHIVED] Center for Drug Evaluation and Research Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin N/A *
October 11, 2002 Pharmakon Laboratories Inc. [ARCHIVED] Center for Drug Evaluation and Research Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin N/A *
October 11, 2002 Boca Pharmacal Inc. [ARCHIVED] Center for Drug Evaluation and Research Certain Drugs Accorded New Drug Status through Rulemaking Procedures/Guaifenesin N/A *



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Contact FDA

ICECI Warning Letters

Division of Freedom of Information (HFI-35)

Food and Drug Administration

5600 Fishers Lane

Rockville, MD 20857
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