More than 1 year after FDA inspectors found a series of problems at Bausch & Lomb's Greenville, SC, solutions manufacturing plant and distribution center, the facilities have received a clean bill of health.
Rochester, NY-More than 1 year after fda inspectors found a series of problems at bausch & lomb's greenville, sc, solutions manufacturing plant and distribution center, the facilities have received a clean bill of health.
The agency inspected the facilities June 29 and found both facilities to be in "acceptable compliance," the company announced July 11.
The FDA had found 20 observations based on inspections conducted March 22, 2006, to May 15, 2006, in an effort to identify any possible sources of Fusarium, which was linked to the contact lens solution (ReNu with MoistureLoc) produced there. The FDA and the Centers for Disease Control and Prevention conducted extensive sampling and testing as part of the joint investigation.
In addition, the FDA said the observations it made then about the plant do not appear connected to the Fusarium contamination or keratitis infections. The observations, included failing to complete a design plan for the contact lens solution and failing to take full measures to prevent contamination of the product.
The FDA also charged Bausch & Lomb for failing to notify the agency of Fusarium keratitis cases in Singapore that were linked to the contact lens solution and for failing to tell the FDA it had removed the contact lens solution from the market there in February 2006.
In October 2006, the FDA issued a warning letter, noting that the company still needed to take corrective actions. By June 29, all corrective actions had been completed with no objectionable observations, the company 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, senior vice president-global operations and engineering, said in a prepared statement.
In other news, a new team of representatives will provide sales support to surgeons in the United States using Bausch & Lomb retina products, the company has announced.
The group will provide support for a microincision cataract surgery system (Millennium) and associated products, a brand of vitreoretinal instruments (Storz), two sustained drug-delivery implants (Retisert and Vitrasert), and an eye vitamin and mineral supplement (PreserVision). Vitreoretinal specialists will provide additional technical and clinical expertise to users of the company's vitreoretinal products.
Edward Kennedy, a 14-year employee of the company, has been appointed director of retina to lead the new team.