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Article: FDA Criticizes Alcon Eye Drug Production Line in Fort Worth, Texas.(Knight Ridder/Tribune Business News)
- Article from:
- Knight Ridder/Tribune Business News
- Article date:
- December 12, 2000
- Author:
CopyrightCOPYRIGHT 2000 Knight-Ridder/Tribune Business News. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Dec. 12--FORT WORTH, Texas--Alcon Laboratories, which makes eye drugs and other eye-care products, has received a warning letter from the Food and Drug Administration, citing problems with one of its production lines at its headquarters in Fort Worth.
The letter, delivered Nov. 17 to Alcon President and Chief Executive Tim Sear, says FDA investigators had documented "serious deviations" from good manufacturing practices.
Mary Dulle, a spokeswoman for Alcon, said the company has addressed the concerns and informed the FDA of its actions.
A spokeswoman for the FDA office in Dallas said the investigation remains open until the agency can determine ...