Bausch & Lomb plant was cited for violations in 2002
The Greenville, South Carolina plant where Bausch & Lomb manufactured its ReNu with MoistureLoc contact lens solution was cited for quality control issues in 2002, according to a July 17, 2002 letter from the Food and Drug Administration. ReNu with MoistureLoc has been linked to an outbreak of the potentially blinding eye infection Fusarium keratitis.
According to the letter, FDA inspectors found paint chips in the rooms where bottles of Bausch & Lomb eye care products, including MoistureLoc, were filled. The FDA wrote the company a month after the inspections, saying that it had failed to properly investigate issues of “product quality” in the plant.
The FDA letter also expressed concern over Bausch & Lomb’s ability to test that the correct amount of preservatives and disinfectants were being added to the bottles. “The specific violations noted in this letter… could be symptomatic of serious underlying problems in your firm’s quality system,” the letter concluded.
News of prior violations at the Greenville plant comes at a bad time for Bausch & Lomb, which is already facing questions about the overall safety of its products. The company issued a ReNu recall in the U.S. after its MoistureLoc solution was linked with more than 100 Fusarium keratitis infections. ReNu lawsuits have already been filed against Bausch & Lomb in New York and Florida.