FDA 483 - Krystal Biotech, Inc. - November 16, 2022

An FDA inspection of Krystal Biotech, Inc. in Pittsburgh, PA, revealed several significant deficiencies in their manufacturing processes. Observations included a lack of quality unit review for drug product production records, failure to prevent objectionable microorganisms, and inadequate pest control leading to insect intrusion in manufacturing areas. Additionally, issues with control over incoming starting materials and drug product vials were noted, indicating a need for improved quality oversight and facility maintenance.