A Medical Device Daily
Eye care company Bausch & Lomb (B&L; Rochester, New York) reported that the FDA has completed an inspection of the company's Greenville, South Carolina, solutions manufacturing plant and distribution center, where the ReNu with MoistureLoc contact lens cleaning solution was made.
The ReNu product was recalled by the company last year (Medical Device Daily, April 17, 2006).
The company said the results of that inspection confirmed its conviction that both facilities are in acceptable compliance.
The assessment of the facility was a follow-up to the agency's inspection conducted during the period March 22 through May 15, 2006. At that time, the FDA issued a Form 483 report containing a series of observations. The company said it responded with a comprehensive plan of corrective actions on June 30, 2006. In October of 2006 the FDA issued a warning letter summarizing the agency's assessment of the corrective actions completed as of June 30, and documenting those corrective actions still in process at the time.
At the conclusion of the most recent inspection on June 29, the agency communicated to the company that all corrective actions had been completed appropriately and no objectionable observations were made.
"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, senior VP global operations and engineering for the company. "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."