FDA 483 - Bausch & Lomb Incorporated - May 15, 2006

The FDA Form 483 details numerous observations from an inspection related to the manufacturing and quality systems for ReNu w/ MoistureLoc Multi-Purpose Solution.

**Facility and Operations:** The inspection covers manufacturing processes for contact lens solutions, including ReNu w/ MoistureLoc, Sensitive Eyes, and Boston Cleaner.

**Violations and Observations:**

* **Design Control Deficiencies:** The design plan for ReNu w/ MoistureLoc was incomplete, lacking descriptions of activities, responsibilities, and interfaces. A complete design plan was not done, and traceability was unclear. Formal feasibility and risk assessment were not performed after combining two preservative formulations in 2004. * **Specification and Testing Issues:** Raw material specifications were not firmly established prior to process validation. Analytical in-process and finished product specifications were not assigned in the design plan or firmly established before launch; for example, the preservative specification was lowered post-process validation. No test method exists to evaluate Alexidine degradation. * **Design History File and Reviews:** The design history file lacked an R&D readiness statement. Incomplete design input requirements were not addressed, with several outstanding for ReNu w/ MoistureLoc prior to market launch. Post-launch product reviews for ReNu w/ MoistureLoc were not performed as required by established procedures (BLR-POL-400), despite the product being distributed since August 2004. * **MDR and Recall Reporting Fail