Lens Solution Plant Inspections. The contact lens solution plant linked to an international outbreak of potentially blinding eye infections had not been inspected by the U.S. Food and Drug Administration for three years, according to the FDA. The Bausch & Lomb plant in Greenville, S.C., the sole producer of all the company’s popular eye-care solutions sold […]
Lens Solution Plant Inspections. The contact lens solution plant linked to an international outbreak of potentially blinding eye infections had not been inspected by the U.S. Food and Drug Administration for three years, according to the FDA.
The Bausch & Lomb plant in Greenville, S.C., the sole producer of all the company’s popular eye-care solutions sold in North America and most of Asia, was cited for significant lapses in manufacturing processes in May and June 2002 the last time it received a regular inspection, FDA records show.
After a March 2003 reinspection found the problems had been corrected, regulators at the FDA didn’t inspect the plant again until last month after growing numbers of consumers in the U.S. and Asia began suffering from a rare but serious eye infection caused by a fungus usually found in soil.
The plants that make the solutions that go in consumers’ eyes are required to be inspected only every two years.
But as was the case at Bausch & Lomb’s plant the FDA acknowledges it rarely meets that standard.
Because it lacks resources and inspectors, the FDA manages to inspect plants only about once every five or six years, sometimes less often, according to agency officials and documents.
The cause of the current eye infection outbreak remains unclear. FDA investigators are looking into whether contamination at the South Carolina plant or the effectiveness of disinfectants in Bausch & Lomb products are factors.
Last week the company asked retailers to pull from their shelves one of the many products produced at the plant: ReNu with MoistureLoc.
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