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	Compound Inc.	Center for Drug Evaluation and Research	Certain Drugs Accorded New Drug Status through Rulemaking Procedures/Guaifenesin	N/A *
October 11, 2002	Alphagen Laboratories Inc.	Center for Drug Evaluation and Research	Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin	N/A *
October 11, 2002	Respa Pharmaceuticals Inc.	Center for Drug Evaluation and Research	Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin	N/A *
October 11, 2002	Ambi Pharmaceuticals	Center for Drug Evaluation and Research	Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin	N/A *
October 11, 2002	Links Pharmaceutical	Center for Drug Evaluation and Research	Certain Drugs Accorded New Drug Status through Rulemaking Procedures/Guaifenesin	N/A *
October 11, 2002	Keil Laboratories Inc.	Center for Drug Evaluation and Research	Certain Drugs Accorded New Drug Status through Rulemaking Procedures/Guaifenesin	N/A *
October 11, 2002	Sage Pharmaceutical	Center for Drug Evaluation and Research	Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin	N/A *
October 11, 2002	Wal Mart Stores Inc.	Center for Drug Evaluation and Research	Certain Drugs Accorded New Drug Status through Rulemaking Procedures/Guaifenesin	N/A *
October 11, 2002	RX PAK DIV Mckesson HBOC	Center for Drug Evaluation and Research	Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin	N/A *
October 11, 2002	H J Harkins Co Inc.	Center for Drug Evaluation and Research	Certain Drugs Accorded New Drug Status through Rulemaking Procedures/Guaifenesin	N/A *
October 11, 2002	Amide Pharmaceutical Inc.	Center for Drug Evaluation and Research	Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin	N/A *
October 11, 2002	Drug Distributors Inc.	Center for Drug Evaluation and Research	Certain Drugs Accorded New Drug Status through Rulemaking Procedures/Guaifenesin	N/A *
October 11, 2002	Vintage Pharmaceutical Inc	Center for Drug Evaluation and Research	Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin	N/A *
October 11, 2002	Direct Dispensing Inc.	Center for Drug Evaluation and Research	Certain Drugs Accorded New Drug Status through Rulemaking Procedures/Guaifenesin	N/A *
October 11, 2002	Anabolic Inc.	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.	Center for Drug Evaluation and Research	Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin	N/A *
October 11, 2002	Major Pharmaceuticals Inc.	Center for Drug Evaluation and Research	Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin	N/A *
October 11, 2002	Caraco Pharmaceutical Laboratories Ltd.	Center for Drug Evaluation and Research	Certain Drugs Accorded New Drug Status through Rulemaking Procedures/Guaifenesin	N/A *
October 11, 2002	Cheshire Pharmaceutical Systems	Center for Drug Evaluation and Research	Certain Drugs Accorded New Drug Status through Rulemaking Procedures/Guaifenesin	N/A *
October 11, 2002	Southwood Pharmaceuticals Inc.	Center for Drug Evaluation and Research	Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin	N/A *

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