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FDA says Bausch & Lomb plant analysis to take another month

Apr 21, 2006 | MarketWatch

The Food and Drug Administration said Friday it could take another month to analyze data from an ongoing inspection of Bausch & Lomb Inc.'s (BOL) Greenville, S.C., plant as part of an effort to locate the source of an outbreak of fungal eye infections associated with the company's contact lens cleaning solution.

On April 10, the Centers for Disease Control and Prevention and the FDA said they were investigating 109 cases of Fusarium keratitis, a fungal infection that can cause blindness, reported in a 10-month period starting last March.

Of the 30 cases that had been reviewed by federal health office While no link has been found between a Bausch & Lomb product and the infection, the company asked retailers last week to pull its ReNu MoistureLoc solution from store shelves until the investigation is complete. The ReNu MoistureLoc solution is used to clean contact lenses.

ReNu with MoistureLoc is made at Bausch's Greenville, S.C.-plant. FDA officials started their inspection of the plant and other facilities on March 22. Among other things, the plant and samples from products at the plant are being tested to see if they are sterile.

On Friday, the FDA said it and the CDC were continuing the inspections and are looking at products, environmental factors and raw materials.

"Because of the nature of the organism (Fusarium), extensive micro-biological testing is being conducted and may take up to one month to fully analyze," the FDA said in a statement Friday.

The company has said it has conducted its own product and plant testing and hasn't found anything to link the ReNu MoistureLoc product to the fungal infections.

The first reports of Fusarium keratitis were among contact lens users in Asia last year, and in February Bausch & Lomb voluntarily suspended sales of its ReNu multipurpose solutions in Singapore and Hong Kong.

Both the CDC and the FDA said they are continuing to receive additional reports of possible Fusarium keratitis cases but haven't released any specific figures so far.


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