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Bausch & Lomb facilities pass FDA re-inspection
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The U.S. Food and Drug Administration recently inspected two Bausch & Lomb facilities in Greenville, S.C., and found them in "acceptable compliance," the company announced in a press release.
The FDA inspected the company's solutions manufacturing plant and distribution center, which had failed a previous inspection.
"At the conclusion of the most recent inspection on June 29, 2007, the agency communicated to the company that all corrective actions had been completed appropriately and no objectionable observations were made," the release said. "The results of that inspection confirmed Bausch & Lomb's conviction that both facilities are in acceptable compliance."
The FDA first inspected the facilities between March 22, 2006, and May 15, 2006, and issued a report of various observations. Bausch & Lomb replied with a "comprehensive plan" of planned corrective actions on June 30, 2006.
In October 2006, the FDA sent Bausch & Lomb a warning letter with an assessment of corrective actions taken as of June 30 and documentation of actions in progress, the release said.
"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," Gerhard Bauer, Bausch & Lomb's senior vice president of global operations and engineering, said in the release. "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."