FDA says ReNu plant was cited for violations in 2002

Wednesday, 19 April 2006

The Greenville, South Carolina plant where Bausch & Lomb manufactured ReNu with MoistureLoc was cited for quality control problems in 2002, according to newly uncovered documents from the Food and Drug Administration. In a July 17, 2002 letter to Bausch & Lomb, the FDA said that it had found loose paint chips in the room where bottles of contact lens solution were filled and faulted the company for failing to properly investigate the source of the chips. The FDA letter also questioned the plant’s ability to ensure that proper amounts of disinfectant and preservatives were being added to lens solutions. Although the problems were restricted to these two areas, the FDA letter expressed concern that they might have larger safety implications for the company. “The specific violations noted in this letter… could be symptomatic of serious underlying problems in your firm’s quality system,” wrote Ballard Graham, the FDA’s Atlanta district director. Revelations of previous health violations at the Greenville plant come at a bad time for Bausch & Lomb, which is already under intense scrutiny after its ReNu with MoistureLoc contact lens solution was linked with an outbreak of the eye infection Fusarium keratitis. Although FDA officials are unsure why so many ReNu with MoistureLoc users are developing the fungal infection, Bausch & Lomb has issued a U.S. ReNu recall until the link is better understood. The Centers for Disease Control and Prevention is currently investigating 109 reports of Fusarium cases in the U.S. for a potential link with MoistureLoc. ReNu lawsuits have already been filed against Bausch & Lomb in Florida and New York.