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FDA releases preliminary B&L inspection findings
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WASHINGTON — The Food and Drug Administration’s preliminary report into Bausch & Lomb’s manufacturing facility in South Carolina indicated the plant deviated “from FDA quality system regulation” in its manufacturing of the contact lens solution, ReNu with MoistureLoc, according to a report on the agency’s Web site.
Additionally, the company was cited for failing to notify the agency of 35 “serious injury reports” of Fusarium keratitis from Singapore’s Minister of Health in February that were related to B&L’s ReNu with MoistureLoc.
An additional five complaints were reported to B&L as early as July 2005, but the FDA was not notified, the agency said in its report. According to the FDA, companies have 30 days to report such findings in writing. Also not reported in writing to the FDA was the company’s decision to pull the solution for the market in both Singapore and Hong Kong in February.
B&L said “within days” of being notified of the situation in Singapore it “discussed those initial case reports” with the FDA, and continued to provide updates to the FDA as they came to light. On April 5, B&L representatives met in person with the FDA to provide a full briefing. The current FDA report cites B&L for not providing the agency with written knowledge of the Fusarium keratitis events.
In addition, B&L states the keratitis complaints from July 2005 cited in the FDA’s report were noninfectious and not related to Fusarium infections. As those incidents did not require medical treatment, the company was not in violation by not reporting it to the FDA, B&L said in a statement.
In late March, the federal agency began its investigation into the plant “to identify any possible source of Fusarium keratitis,” which has been associated with contact lens wearers who used the ReNu with MoistureLoc. Since then, B&L has withdrawn the product from worldwide distribution.
During the inspection of the plant, the FDA and the Centers for Disease Control and Prevention conducted “extensive sampling and testing as part of the joint investigation. Preliminary results to date from testing of environmental factors, raw materials, in-line manufacturing processes and finished products have not found that these factors have contributed to the Fusarium contamination,” the report said.
B&L has suggested the lens solution formulation may be the cause of the increased relative risk of the fungal keratitis infections. However, the FDA inspection observations “do not necessarily support a connection between the formulation of the ReNu with MoistureLoc product and the Fusarium keratitis infections.”
As of May 12, the CDC has received reports of 122 confirmed cases of Fusarium keratitis, 15 possible cases and 60 cases still under investigation from 33 U.S. states and territories.
The FDA said “it is premature to conclude that some of the observations cited in the report are associated with the cases of Fusarium keratitis.”