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

 

Posted on May 04, 2009

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
October 11, 2002	KV Pharmaceutical Co	Center for Drug Evaluation and Research	Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin	N/A *
October 11, 2002	Liberty Pharmaceuticals	Center for Drug Evaluation and Research	Certain Drugs Accorded New Drug Status through Rulemaking Procedures/Guaifenesin	N/A *
October 11, 2002	DRX Pharmaceutical Consultants Inc.	Center for Drug Evaluation and Research	Certain Drugs Accorded New Drug Status through Rulemaking Procedures/Guaifenesin	N/A *
October 11, 2002	Pharmacy Care Plus LC	Center for Drug Evaluation and Research	Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin	N/A *
October 11, 2002	Qualitest Pharmaceuticals Inc.	Center for Drug Evaluation and Research	Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin	N/A *
October 11, 2002	Pharmakon Laboratories Inc.	Center for Drug Evaluation and Research	Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin	N/A *
October 11, 2002	Martec Pharmaceuticals Inc.	Center for Drug Evaluation and Research	Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin	N/A *
October 11, 2002	ST International Inc.	Center for Drug Evaluation and Research	Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin	N/A *
October 11, 2002	Ivax Laboratories	Center for Drug Evaluation and Research	Certain Drugs Accorded New Drug Status through Rulemaking Procedures/Guaifenesin	N/A *
October 11, 2002	Corepharma LLC	Center for Drug Evaluation and Research	Certain Drugs Accorded New Drug Status through Rulemaking Procedures/Guaifenesin	N/A *
October 11, 2002	Stewart Jackson Pharmacal	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	Center for Drug Evaluation and Research	Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin	N/A *
October 11, 2002	Seatrace Pharmaceuticals Inc.	Center for Drug Evaluation and Research	Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin	N/A *
October 11, 2002	Neil Laboratories Inc.	Center for Drug Evaluation and Research	Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin	N/A *
October 11, 2002	Ethex Corp	Center for Drug Evaluation and Research	Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin	N/A *
October 11, 2002	PDRX Pharmaceuticals Inc.	Center for Drug Evaluation and Research	Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin	N/A *
October 11, 2002	United Research Laboratories Inc.	Center for Drug Evaluation and Research	Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin	N/A *
October 11, 2002	Sidmak Laboratories Inc.	Center for Drug Evaluation and Research	Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin	N/A *
October 11, 2002	Heartland Repack Services LLC	Center for Drug Evaluation and Research	Certain Drugs Accorded New Drug Status through Rulemaking Procedures/Guaifenesin	N/A *
October 11, 2002	Vangard Labs Inc.	Center for Drug Evaluation and Research	Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin	N/A *

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