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

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.