Krystal Biotech, Inc.
FDA inspection history in Pittsburgh, Pennsylvania, 2022 to 2025
- 2
- Form 483s
Every document, by year
- Form 483
2022: one Form 483; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2022One Form 483, at Pittsburgh, Pennsylvania.
- 2022The longest 483 on file: 4 observations over 2 pages at Pittsburgh, Pennsylvania.
- 2025One Form 483, at Pittsburgh, Pennsylvania.
Cited most
Across all Krystal Biotech observations on file
- 21 CFR 211.192Production record review2
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures2
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.56Sanitation1
The complete Krystal Biotech file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Pittsburgh, Pennsylvania
Two Form 483s · 2022 to 2025 · 4 observations
Latest: Form 483, Jan 30, 2025 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-01-30 | 483 Form 483 | Pittsburgh, Pennsylvania | — | $99 |
| 2022-11-16 | 483 Form 483 | Pittsburgh, Pennsylvania | 4 | $99 |
Investigators on these documents
Anna Kwilas (1)Bo Liang (1)Carl Perez (1)Jianyang Wang (1)Lewis K. Antwi (1)Priscilla M. Pastrana (1)Richard L. Bartlett (1)Wei Wang (1)
FEI number 3013498720 · most recent document Jan 30, 2025
About Krystal Biotech, Inc.
How many FDA Form 483s has Krystal Biotech, Inc. received?
FDA Intel has 2 Form 483s on file for Krystal Biotech, Inc.; the most recent is dated Jan 30, 2025.
When was Krystal Biotech, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Krystal Biotech, Inc. is a Form 483 dated Jan 30, 2025, for the site in Pittsburgh, Pennsylvania.
What did FDA cite at Krystal Biotech, Inc.?
The regulations cited most in the observations on file for Krystal Biotech, Inc. are 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.84 (Testing and approval or rejection of components, drug product containers, and closures), 2 times; 21 CFR 211.113 (Control of microbiological contamination), 1 time.