Better Late than Never
July 16, 2007
Bausch & Lomb’s contact lens solution plant here has cleared inspection by federal regulators, the Food and Drug Administration said Thursday.
The plant had made the company’s Renu with MoistureLoc solution that was discontinued last year after it was connected to several hundred cases of a rare, but dangerous eye infection called Fusarium keratitis in parts of Asia and the United States.
The FDA inspected the plant last year and found several problems with production, including failure to properly test solutions and check suppliers. The government also said Bausch & Lomb failed to disclose links between the infection and its product discovered in Asia before the U.S. recall.
The FDA ruled out problems in the manufacturing process as contributing to the eye infections, Bausch & Lomb spokesman Michael L. McDougall said.