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B&L lens care solution facility

This article was originally published in The Gray Sheet

Executive Summary

Bausch & Lomb's Greenville, S.C., contact lens solution plant clears FDA inspection June 29. The Greenville plant had manufactured the firm's ReNu with MoistureLoc lens care solution, which was withdrawn from the market last May after being linked to reports of fusarium keratitis infections. FDA issued a warning letter to the plant in October, citing failure to promptly notify the agency of adverse events, inadequate process validation, and lack of procedures to prevent product or equipment contamination, among other quality systems concerns (1"The Gray Sheet" Nov. 13, 2006, p. 18). According to B&L, FDA is now satisfied that the firm has completed all of its corrective actions...
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