FDA EIR - Bausch & Lomb Incorporated - October 27, 2006

An FDA inspection of Bausch & Lomb, Inc. in Tampa, FL, conducted from October 23 to 27, 2006, focused on compliance with Medical Device PMA, Drug Manufacturing, and Medical Device Quality System regulations. While no formal FDA 483 was issued, ten deficiencies were identified, primarily concerning the Ocucoat medical device manufacturing process and general quality systems. Key issues included the need for an enhanced container closure study for Ocucoat, comprehensive identification of microbiological contaminants in classified areas, and evaluation of the fill line transport system for potential contamination. The inspection also highlighted the necessity for more detailed acceptance criteria and better-defined validation activities for Ocucoat, including re-executing sealer validation with statistically significant samples. Furthermore, the Device Master Record for Ocucoat required inclusion of quality assurance steps for packaging inspection and a final packaging integrity test post-sterilization. General improvements involved verifying Biological Indicator resistance testing against established standards and changing the gas used during media fills to ensure detection of a broader range of microbial contamination. Bausch & Lomb's management acknowledged the observations, promising prompt corrective actions and a written response to address these concerns.