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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 Martec Pharmaceuticals Inc. [ARCHIVED] Center for Drug Evaluation and Research Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin N/A *
October 11, 2002 RX PAK DIV Mckesson HBOC [ARCHIVED] Center for Drug Evaluation and Research Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin N/A *
October 11, 2002 Ranbaxy Pharmaceuticals Inc. [ARCHIVED] Center for Drug Evaluation and Research Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin N/A *
October 11, 2002 Stewart Jackson Pharmacal [ARCHIVED] Center for Drug Evaluation and Research Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin N/A *
October 11, 2002 Physicians Total Care Inc [ARCHIVED] Center for Drug Evaluation and Research Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin N/A *
October 11, 2002 Seatrace Pharmaceuticals Inc. [ARCHIVED] Center for Drug Evaluation and Research Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin N/A *
October 11, 2002 Neil Laboratories Inc. [ARCHIVED] Center for Drug Evaluation and Research Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin N/A *
October 11, 2002 Ethex Corp [ARCHIVED] Center for Drug Evaluation and Research Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin N/A *
October 11, 2002 Drug Distributors Inc. [ARCHIVED] Center for Drug Evaluation and Research Certain Drugs Accorded New Drug Status through Rulemaking Procedures/Guaifenesin N/A *
October 11, 2002 Vintage Pharmaceutical Inc [ARCHIVED] Center for Drug Evaluation and Research Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin N/A *
October 11, 2002 Direct Dispensing Inc. [ARCHIVED] Center for Drug Evaluation and Research Certain Drugs Accorded New Drug Status through Rulemaking Procedures/Guaifenesin N/A *
October 11, 2002 Anabolic Inc. [ARCHIVED] Center for Drug Evaluation and Research Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin N/A *
October 11, 2002 National Pharmpak Services [ARCHIVED] Center for Drug Evaluation and Research Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin N/A *
October 11, 2002 Dartmouth Pharmaceuticals Inc. [ARCHIVED] Center for Drug Evaluation and Research Certain Drugs Accorded New Drug Status through Rulemaking Procedures/Guaifenesin N/A *
October 11, 2002 Nucare Pharmaceuticals Inc. [ARCHIVED] Center for Drug Evaluation and Research Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin N/A *
October 11, 2002 Cypress Pharmaceutical Inc. [ARCHIVED] Center for Drug Evaluation and Research Certain Drugs Accorded New Drug Status through Rulemaking Procedures/Guaifenesin N/A *
October 11, 2002 Caraco Pharmaceutical Laboratories Ltd. [ARCHIVED] Center for Drug Evaluation and Research Certain Drugs Accorded New Drug Status through Rulemaking Procedures/Guaifenesin N/A *
October 11, 2002 Cheshire Pharmaceutical Systems [ARCHIVED] Center for Drug Evaluation and Research Certain Drugs Accorded New Drug Status through Rulemaking Procedures/Guaifenesin N/A *
October 11, 2002 Southwood Pharmaceuticals Inc. [ARCHIVED] Center for Drug Evaluation and Research Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin N/A *
October 11, 2002 Prestige Packaging Inc. [ARCHIVED] Center for Drug Evaluation and Research Certain Drugs Accord 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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