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

Source: https://www.globalkeysolutions.net/records/483/bausch-lomb-incorporated/7d50142b-ed55-41e3-b196-18edb1340d4e

> FDA 483 for Bausch & Lomb Incorporated on May 15, 2006. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bausch & Lomb Incorporated
- Inspection Date: 2006-05-15
- Product Type: Drugs
- Office Name: Atlanta District Office
- Summary: 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

## Related Documents

- [483 - 2025-02-27](https://www.globalkeysolutions.net/records/483/bausch-lomb-incorporated/01c8a6ee-84d6-4898-9b59-37e38def9333)

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Company: https://www.globalkeysolutions.net/companies/bausch-lomb-incorporated/989fe252-9728-4751-92ab-c4b18fa5eff8

Office: https://www.globalkeysolutions.net/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7