FDA Form 483 Krystal Biotech Inc., Pittsburgh, PA Jan 2025
Form 483 issued January 30, 2025 · Pittsburgh, Pennsylvania
- Investigators
- Lewis K. Antwi· Richard L. Bartlett
- Observations
- 2
- Pages
- 4
In short: On January 30, 2025, FDA issued a Form 483 with 2 observations to FDA Form 483 Krystal Biotech Inc., Pittsburgh, PA Jan 2025 in Pittsburgh, Pennsylvania. 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 has…
- 02
Observation 2: scanned text, readable in the full document.
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 firmFDA Form 483 Krystal Biotech Inc., Pittsburgh, PA Jan 2025 history
The site's inspection history, in date order.
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 FDA Form 483 Krystal Biotech Inc., Pittsburgh, PA Jan 2025?
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 FDA Form 483 Krystal Biotech Inc., Pittsburgh, PA Jan 2025?
Lewis K. Antwi and Richard L. Bartlett are named on this Form 483. Each investigator has a profile showing what they cite most.
When was FDA Form 483 Krystal Biotech Inc., Pittsburgh, PA Jan 2025 inspected by FDA?
This Form 483 is dated January 30, 2025.
How do I get the full Form 483 for FDA Form 483 Krystal Biotech Inc., Pittsburgh, PA Jan 2025?
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.