2002 Warning Letters

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Tobacco Retailer Warning Letters

 

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 15, 2002	Ports Seafood, Inc.	San Francisco District Office	Seafood HACCP/Adulterated	N/A *
October 15, 2002	The Outer Banks Hospital	Atlanta District Office	Mammography Quality Standards	N/A *
October 11, 2002	Ranbaxy Pharmaceuticals Inc.	Center for Drug Evaluation and Research	Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin	N/A *
October 11, 2002	Kaiser FDN Health Plan Colorado	Center for Drug Evaluation and Research	Certain Drugs Accorded New Drug Status through Rulemaking Procedures/Guaifenesin	N/A *
October 11, 2002	Mikart Inc	Center for Drug Evaluation and Research	Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin	N/A *
October 11, 2002	National Pharmpak Services	Center for Drug Evaluation and Research	Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin	N/A *
October 11, 2002	Dartmouth Pharmaceuticals Inc.	Center for Drug Evaluation and Research	Certain Drugs Accorded New Drug Status through Rulemaking Procedures/Guaifenesin	N/A *
October 11, 2002	Nucare Pharmaceuticals Inc.	Center for Drug Evaluation and Research	Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin	N/A *
October 11, 2002	Sovereign Pharmaceutical Inc.	Center for Drug Evaluation and Research	Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin	N/A *
October 11, 2002	Amerisource Health Services Corp.	Center for Drug Evaluation and Research	Certain Drugs Accorded New Drug Status through Rulemaking Procedures/Guaifenesin	N/A *
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 *
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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