# FDA 483 - Bausch & Lomb, Inc. - November 22, 2024

Source: https://www.globalkeysolutions.net/records/483/bausch-lomb-inc/fc245432-57c1-4a6f-9cd6-1b81fcb56c87

> FDA 483 for Bausch & Lomb, Inc. on November 22, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bausch & Lomb, Inc.
- Inspection Date: 2024-11-22
- Product Type: device
- Office Name: Kansas City District Office
- Summary: An FDA inspection of Bausch & Lomb, Inc. in Manchester, MO, revealed significant deficiencies in their quality system for medical instrument manufacturing. The firm failed to adequately establish procedures for finished device acceptance, leading to the release of non-conforming lots without proper control or evaluation. Additionally, the company lacked adequate corrective and preventive action procedures, failing to investigate recurring nonconformities and implement necessary changes following customer complaints.

## Related Officers

- [Edward E. Lockwood](https://www.globalkeysolutions.net/people/edward-e-lockwood/3260b39e-9211-489f-8247-0ec3353e57ca)

Company: https://www.globalkeysolutions.net/companies/bausch-lomb-inc/eb33b19b-e9d4-4f4b-960b-e770091990d3

Office: https://www.globalkeysolutions.net/offices/kansas-city-district-office/cd397ab1-df4e-46f1-ab1c-0f6db9abcf79