# FDA 483 - Bausch & Lomb Incorporated - February 28, 2020

Source: https://www.keypedia.com/records/483/bausch-lomb-incorporated/4f882f1a-50c4-43c8-8c38-383a4d0b2b2f

> FDA 483 for Bausch & Lomb Incorporated on February 28, 2020. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Bausch & Lomb Incorporated
- Inspection Date: 2020-02-28
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Bausch & Lomb Irvine, an API drug manufacturer in Irvine, CA, was cited for significant deficiencies in its quality system and laboratory controls. Observations included a lack of quality agreements with contract labs, unsupported API expiration dates, failure to follow QC procedures, and inadequate investigations into product discrepancies. The firm also had issues with its HPLC test procedures and chromatographic data review.

## Related Officers

- [Professor](https://www.keypedia.com/people/liming-zhang/6c93b721-8725-4d87-8a42-254f3de5e49d)

Company: https://www.keypedia.com/companies/bausch-lomb-incorporated/961e1d16-e42e-477e-a270-c3473a10fad3

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6