# FDA 483 - Krystal Biotech, Inc. - January 30, 2025

Source: https://www.keypedia.com/records/483/krystal-biotech-inc/6052640f-1207-4f00-b797-0b772a72f82f

> FDA 483 for Krystal Biotech, Inc. on January 30, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Krystal Biotech, Inc.
- Inspection Date: 2025-01-30
- Product Type: biologics
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of Krystal Biotech, Inc. in Pittsburgh, PA, revealed significant deficiencies in their quality system. The firm failed to thoroughly investigate approximately 30 deviations related to drug substance manufacturing for VYJUVEK, leading to the release of commercial batches without adequate corrective actions. Additionally, the company did not establish the reliability of supplier Certificates of Analysis for critical components.

## Related Documents

- [483 - 2022-11-16](https://www.keypedia.com/records/483/krystal-biotech-inc/bc54c53c-606d-4637-b5cc-115b3eb0c9e7)

## Related Officers

- [Richard L. Bartlett](https://www.keypedia.com/people/richard-l-bartlett/602337b9-ac77-41bb-a254-71a9d345335b)
- [Lewis K. Antwi](https://www.keypedia.com/people/lewis-k-antwi/8ab4f1c7-8b5b-4556-98a4-6edc3bc49470)

Company: https://www.keypedia.com/companies/krystal-biotech-inc/a9722688-fbec-493a-b344-89b3fb41b9ab

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8