# FDA 483 - AmbioPharm, Inc - February 09, 2023

Source: https://www.keypedia.com/records/483/ambiopharm-inc/f5b141ab-3baf-4e5b-9481-6e991f46418e

> FDA 483 for AmbioPharm, Inc on February 09, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AmbioPharm, Inc
- Inspection Date: 2023-02-09
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: AmbioPharm, Inc. in Beech Island, SC, a peptide-drug substance manufacturer, received a Form 483 with two significant observations. The inspection revealed issues with the QC laboratory's handling of out-of-specification results, including repeated invalidations and re-testing without adequate controls, and a lack of real-time data documentation. Additionally, the firm failed to maintain sufficient control over its water systems, leading to persistent microbial contamination and objectionable organisms in components used for drug substances.

## Related Officers

- [Lilia M Lugo](https://www.keypedia.com/people/lilia-m-lugo/bd409997-f589-4d2d-b7ba-4b52f222e43e)

Company: https://www.keypedia.com/companies/ambiopharm-inc/6a51f093-2f5b-433d-8e97-8e33820a50bf

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