FDA Criticizes Alcon Eye Drug Production Line in Fort Worth, Texas.

Byline: Mitchell Schnurman nestle

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 that the required corrections have been made.

The FDA sends hundreds of warning letters annually, and only a few result in significant agency action. Still, the letters can be the last notice before the FDA takes steps such as holding up approvals of new products or pursuing civil fines.

The FDA conducted a routine inspection at Alcon from Oct. 12 to Oct. 27, the letter says. The agency cited six problem areas, primarily involving procedures to ensure that products and ...