# FDA 483 - Bausch & Lomb Incorporated - February 27, 2025

Source: https://www.keypedia.com/records/483/bausch-lomb-incorporated/01c8a6ee-84d6-4898-9b59-37e38def9333

> FDA 483 for Bausch & Lomb Incorporated on February 27, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bausch & Lomb Incorporated
- Inspection Date: 2025-02-27
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Bausch & Lomb Incorporated in Greenville, SC, a sterile drug manufacturer, revealed significant deficiencies in preventing microbiological contamination, including inadequate sterilization rationales, flawed media fills, and compromised ISO-5 air spaces. The inspection also cited issues with drug product specifications lacking sampling plans and equipment maintenance procedures for raw ingredient dispensing scales. These observations indicate a need for improved controls to ensure the sterility and quality of ophthalmic drug products.

## Related Documents

- [483 - 2006-05-15](https://www.keypedia.com/records/483/bausch-lomb-incorporated/7d50142b-ed55-41e3-b196-18edb1340d4e)

## Related Officers

- [Drug Specialist  / Drug Investigator](https://www.keypedia.com/people/saundrea-a-munroe/129a869f-e1f2-4d59-b3ed-9613a9190f8a)

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

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