# FDA 483 - Bausch & Lomb Incorporated - November 25, 2019

Source: https://www.keypedia.com/records/483/bausch-lomb-incorporated/39481b0e-3bbf-4313-8745-597e4e88b55c

> FDA 483 for Bausch & Lomb Incorporated on November 25, 2019. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Bausch & Lomb Incorporated
- Inspection Date: 2019-11-25
- Product Type: drugs
- Office Name: New York District Office
- Summary: Bausch & Lomb Inc. in Rochester, NY, a control testing laboratory, received a Form 483 with two observations. The inspection revealed deficiencies in the quality control unit's document control process for laboratory worksheets, lacking proper issuance and audit trail. Additionally, the facility's sterility testing room was found to be in a poor state of repair, with missing ceiling tiles and rusted vents, indicating inadequate maintenance.

## Related Officers

- [Johnna L. Bleem](https://www.keypedia.com/people/johnna-l-bleem/3fe669bf-e354-4cdc-9337-d5ceb23f1c9f)

Company: https://www.keypedia.com/companies/bausch-lomb-incorporated/dd8b3ac8-3a34-4f06-a0c1-64323a0da668

Office: https://www.keypedia.com/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d