FDA Cited Contact Lens Solution Plant in 2002

Archives Admin · #1 (**permalink**) 04-20-2006, 12:32 PM

The optical solutions plant at the center of an investigation into cases of eye fungus was cited by the federal Food and Drug Administration for quality control problems in 2002.

Last week, Rochester, N.Y.-based Bausch & Lomb stopped shipment of the contact lens solution Renu with MoistureLoc while federal health officials try to determine whether the solution is linked to more than 100 cases of eye fungus.

During inspections in May and June 2002 at Bausch & Lomb’s Greenville, S.C., plant, the FDA discovered paint chips in rooms where containers of eye care products were filled. The FDA said the company failed to adequately investigate the cause of the paint chips, “which directly related to product quality,” according to a warning letter dated July 17, 2002.

The warning letter also raised concerns about the plant’s ability to test for the appropriate amount of preservative and disinfectant “used in the majority of your eye care products.”

“The specific violations noted in this letter … could be symptomatic of serious underlying problems in your firm’s quality system,” said the letter, signed by Ballard Graham, director of the FDA’s Atlanta district at the time.

The Atlanta Journal-Constitution, which first reported the inspections in Wednesday’s editions, said the Greenville plant passed inspection in March 2003 and was not reinspected until last month, after the first cases of eye fungus were reported.

Renu with MoistureLoc wasn’t manufactured until 2004.

Meg Graham, director of corporate communications for Bausch & Lomb, said the warning letter reflected only a problem with the way the company documented the paint chip problem. The company discovered the paint chips during a routine plant inspection and remedied the problem, she said.

“The quality and sterility of the products made there was never in question,” Graham said.

The fungus, Fusarium keratitis, is commonly found in plant material and soil in tropical and subtropical regions. Without eyedrop treatment, the infection can scar the cornea and blind its victims.

Federal health officials have made no direct link between MoistureLoc and the infections, but a high incidence of the dozens of affected patients interviewed so far had used the cleaner.

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FDA Cited Contact Lens Solution Plant in 2002

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