Bausch & Lomb facility passes FDA inspection

August 1, 2007

Rochester, NY-The Bausch & Lomb solutions manufacturing and distribution center in Greenville, SC, has been determined to be in acceptable compliance after an inspection by the FDA.

Rochester, NY-The Bausch & Lomb solutions manufacturing and distribution center in Greenville, SC, has been determined to be in acceptable compliance after an inspection by the FDA.

The assessment of the facility was a follow-up to the agency’s inspection of that center and a related one, conducted March 22 through May 15, 2006, as part of an investigation into an increase in Fusarium keratitis infections associated with contact lens wearers using a particular lens-cleaning solution (ReNu with MoistureLoc). At the end of that inspection period, the FDA issued a report with observations about deviations from the agency’s quality system regulation, to which the company responded with a plan of corrective actions on June 30, 2006.

In October, the FDA issued a warning letter summarizing the agency’s assessment of the corrective actions completed as of the June 2006 date and documenting the corrective actions that still were in progress at the time. At the conclusion of the most recent inspection June 29, the agency told the company that all corrective actions had been completed appropriately and that no objectionable observations were made, according to a statement from Bausch & Lomb.

“Bausch & Lomb is committed to continuous improvement in all aspects of our business and to maintaining our operations in compliance with all regulatory requirements and good manufacturing practices,” said Gerhard Bauer, Bausch & Lomb senior vice president, global operations and engineering. “We are pleased that this inspection confirmed the successful implementation of all commitments made by Bausch & Lomb to the FDA, an outcome made possible through the efforts and dedication of our Greenville employees.”