SEAGEN INC
Form 483 issued May 13, 2025 · Bothell, Washington
- Inspection
- May 1 – May 13, 2025
- Investigator
- Christopher R. Czajka
- Observations
- 1
- Pages
- 3
- FEI number
- 3002781621
In short: On May 13, 2025, FDA issued a Form 483 with 1 observation to SEAGEN INC in Bothell, Washington (FEI 3002781621) after an inspection that ran May 1 – May 13, 2025. The investigator was Christopher R. Czajka. Most observations concern quality system; the most-cited regulation is 21 CFR 211.25 (personnel qualifications).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.25(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Employees engaged in the packing of a drug product lack the training required to…
This inspection in context
Christopher R. Czajka
37 documents · 2015–2025
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in California.
The firmSEAGEN INC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.25(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at SEAGEN INC?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.25 (personnel qualifications). The opening words of each observation are shown on this page.
Who inspected SEAGEN INC?
Christopher R. Czajka is named on this Form 483, for the inspection of May 1 – May 13, 2025. Each investigator has a profile showing what they cite most.
When was SEAGEN INC inspected by FDA?
The inspection ran May 1 – May 13, 2025, and the Form 483 is dated May 13, 2025.
How do I get the full Form 483 for SEAGEN 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.