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

Source: https://www.keypedia.com/records/483/andelyn-biosciences-inc/cc595bf9-cc90-4bc8-b625-d6472d92b0eb

> 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: Office of Medical Device and Radiological Health Operations
- Summary: Amelyn Biosciences, Inc. in Columbus, OH, was cited for multiple significant deficiencies during an FDA inspection, primarily concerning inadequate quality oversight, environmental controls, and facility qualification for drug substance manufacturing. The observations highlight systemic failures in deviation management, documentation, training, utility monitoring, and disinfectant efficacy, indicating a lack of robust control over critical processes and potential risks to product quality.

## Related Documents

- [483 - 2025-05-30](https://www.keypedia.com/records/483/andelyn-biosciences-inc/06a9b41a-5abd-4e85-a3e5-d85d58fc9fd3)
- [483 - 2025-05-30](https://www.keypedia.com/records/483/andelyn-biosciences-inc/62b74c86-cb52-4404-91fd-1766e504cd61)

## Related Officers

- [Holly Brevig](https://www.keypedia.com/people/holly-brevig/68a8fca4-e80e-40f2-9ecc-4b4bcfcd8d1d)
- [Susan S. Butler](https://www.keypedia.com/people/susan-s-butler/45011bf3-2074-4150-aafe-1eac320c0864)
- [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/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4