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	Prestige Packaging Inc.	Center for Drug Evaluation and Research	Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin	N/A *
October 11, 2002	Boca Pharmacal Inc.	Center for Drug Evaluation and Research	Certain Drugs Accorded New Drug Status through Rulemaking Procedures/Guaifenesin	N/A *
October 11, 2002	Celltech Manufacturing Inc.	Center for Drug Evaluation and Research	Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin	N/A *
October 11, 2002	Eckerd Drug Co	Center for Drug Evaluation and Research	Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin	N/A *
October 11, 2002	Capellon Pharmaceuticals Inc.	Center for Drug Evaluation and Research	Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin	N/A *
October 11, 2002	Iopharm Laboratories Inc.	Center for Drug Evaluation and Research	Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin	N/A *
October 11, 2002	Cypress Pharmaceutical Inc.	Center for Drug Evaluation and Research	Certain Drugs Accorded New Drug Status through Rulemaking Procedures/Guaifenesin	N/A *
October 11, 2002	Pharmaceutical Utilization Management Program VA Inc.	Center for Drug Evaluation and Research	Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin	N/A *
October 11, 2002	Duramed Pharmceuticals Inc.	Center for Drug Evaluation and Research	Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin	N/A *
October 11, 2002	Goldline Laboratories	Center for Drug Evaluation and Research	Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin	N/A *
October 11, 2002	Thrift Drug Services	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	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	Center for Drug Evaluation and Research	Certain Drugs Accorded New Drug Status through Rulemaking Procedures/Guaifenesin	N/A *
October 11, 2002	Keil Pharmaceuticals Inc.	Center for Drug Evaluation and Research	Certain Drugs Accorded New Drug Status through Rulemaking Procedures/Guaifenesin	N/A *
October 11, 2002	Biovail Pharmaceuticals Inc.	Center for Drug Evaluation and Research	Certain Drugs Accorded New Drug Status through Rulemaking Procedures/Guaifenesin	N/A *
October 11, 2002	PFAB LP - Pharmafab	Center for Drug Evaluation and Research	Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin	N/A *
October 11, 2002	Allscripts Healthcare Solutions	Center for Drug Evaluation and Research	Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin	N/A *
October 11, 2002	UBC Pharma Inc.	Center for Drug Evaluation and Research	Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin	N/A *
October 11, 2002	Jerome Stevens Pharmaceuticals Inc.	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.	Center for Drug Evaluation and Research	Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin	N/A *

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