# FDA 483 - Andelyn Biosciences, Inc. - May 30, 2025

Source: https://www.keypedia.com/records/483/andelyn-biosciences-inc/06a9b41a-5abd-4e85-a3e5-d85d58fc9fd3

> FDA 483 for Andelyn Biosciences, Inc. on May 30, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Andelyn Biosciences, Inc.
- Inspection Date: 2025-05-30
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: Analyn Biosciences, Inc. in Columbus, OH, received a Form 483 citing significant deficiencies in quality oversight, environmental monitoring, and utility management during the manufacture of drug substance. The inspection revealed inadequate deviation management, poor documentation practices, and insufficient training, alongside issues with cleanroom qualification and disinfectant efficacy studies. These findings indicate a lack of robust controls necessary to ensure product quality and compliance.

## Related Officers

- [Susan S. Butler](https://www.keypedia.com/people/susan-s-butler/45011bf3-2074-4150-aafe-1eac320c0864)
- [Holly Brevig](https://www.keypedia.com/people/holly-brevig/68a8fca4-e80e-40f2-9ecc-4b4bcfcd8d1d)
- [Jacob L. Bitterman](https://www.keypedia.com/people/jacob-l-bitterman/f1868456-2053-4738-a158-93d921a06258)

Company: https://www.keypedia.com/companies/andelyn-biosciences-inc/767017ae-d0c1-486f-b6ee-140770cf066e

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22