Krystal Biotech, Inc.
Form 483 issued January 30, 2025 · Pittsburgh, Pennsylvania
- Inspection
- Jan 22 – Jan 30, 2025
- Investigators
- Lewis K. Antwi· Richard L. Bartlett
- Observations
- 2
- Pages
- 4
- FEI number
- 3013498720
In short: On January 30, 2025, FDA issued a Form 483 with 2 observations to Krystal Biotech, Inc. in Pittsburgh, Pennsylvania (FEI 3013498720) after an inspection that ran Jan 22 – Jan 30, 2025. The investigators were Lewis K. Antwi and Richard L. Bartlett. Most observations concern quality system and materials; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and materials account for 2 of 2 observations.
Most cited: 21 CFR 211.192 (1×) · 211.84 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
Failure to check the reliability of Certificate of Analysis…
This inspection in context
Lewis K. Antwi
11 documents · 2019–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmKrystal Biotech, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Krystal Biotech, Inc.?
FDA listed 2 observations on this Form 483, mostly about quality system and materials. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Krystal Biotech, Inc.?
Lewis K. Antwi and Richard L. Bartlett are named on this Form 483, for the inspection of Jan 22 – Jan 30, 2025. Each investigator has a profile showing what they cite most.
When was Krystal Biotech, Inc. inspected by FDA?
The inspection ran Jan 22 – Jan 30, 2025, and the Form 483 is dated January 30, 2025.
How do I get the full Form 483 for Krystal Biotech, Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.