FDA Says Bausch & Lomb's S.C. Plant Not Contaminated

WASHINGTON, D.C. - Preliminary results from an FDA investigation of Bausch & Lomb's Greenville, S.C., plant show that environmental factors, raw materials, in-line manufacturing processes and finished products did not contribute to ReNu® with MoistureLoc's Fusarium contamination.

However, on May 16, the FDA said its investigator observed deviations from FDA quality system regulation, indicating possible divergence from current good manufacturing practice. Laboratory testing is ongoing, the agency added.

Bausch & Lomb has proposed the ReNu with MoistureLoc formulation as the potential root cause of the increased relative risk of Fusarium keratitis, the FDA said, noting that the observations from the …