ROCHESTER, N.Y. – Bausch & Lomb (NYSE/BOL) today announced that the United States Food and Drug Administration (FDA) has completed an inspection of the company’s Greenville, S.C. solutions manufacturing plant and distribution center. The results of that inspection confirmed Bausch & Lomb’s 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 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, 2007, 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 vice president-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.”
Bausch & Lomb is the eye health company, dedicated to perfecting vision and enhancing life for consumers around the world. Its core businesses include soft and rigid gas permeable contact lenses and lens care products, and ophthalmic surgical and pharmaceutical products. The Bausch & Lomb name is one of the best known and most respected healthcare brands in the world. Founded in 1853, the Company is headquartered in Rochester, New York, and employs approximately 13,000 people worldwide. Its products are available in more than 100 countries. More information about the Company can be found on the Bausch & Lomb Internet site at www.bausch.com. Copyright Bausch & Lomb Incorporated.