FDA inspection

Krystal Biotech, Inc.: FDA inspection ending Jan 30, 2025

FDA inspection 1259522 · Voluntary Action Indicated (VAI) · Pittsburgh, PA

Key facts

Inspection ID 1259522
Firm Krystal Biotech, Inc.
FEI number 3013498720
Address 2100 Wharton St Ste 701
City Pittsburgh
State PA
ZIP 15203
Country United States
Fiscal year 2025
Inspection end date Jan 30, 2025
Classification Voluntary Action Indicated (VAI)
Project area Human Cellular, Tissue, and Gene Therapies
Product type Biologics

At a glance

  • None Citations
  • 1–9 Posted citations
  • No Warning letter followed
  • Yes Form FDA 483 issued
  • Yes Establishment inspection report (EIR) exists
  • 1–9 Inspections at this FEI

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA inspections

FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.

Source: U.S. Food and Drug Administration (FDA), inspection classification data

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