Atlas

FDA-Inspected Site

SEAGEN INC.

12 FDA inspections are on record for SEAGEN INC. in Bothell, United States.

483· Form 483 issued

Bothell, United States · Last updated July 9, 2026

Overview

  • 12 FDA inspections are on record.
  • 7 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-05-13.

At a glance

Inspections

12

Form 483s

7

EIRs

1

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
1 May 2025 – 13 May 2025Human Drugs483View 483 →
28 Oct 2024 – 1 Nov 2024Human DrugsClean
29 Apr 2024 – 2 May 2024Human DrugsClean
3 Jun 2022 – 10 Jun 2022Human Drugs483On file
16 Jan 2020 – 24 Jan 2020Human DrugsClean
1 Oct 2019 – 4 Oct 2019Human DrugsClean
3 Jan 2018 – 5 Jan 2018Human DrugsClean
19 Apr 2017 – 1 May 2017Human Drugs483View 483 →
27 May 2015 – 9 Jun 2015Human Drugs483View 483 →
6 Mar 2013 – 20 Mar 2013Human Drugs483View 483 →
19 Jul 2011Not recorded483View 483 →
19 May 2011Not recorded483On file

Observations on record

Form 483 observations cited at this site, most recent first.

13 May 2025
21 CFR 211.25(a)

Training , Education , Experience overall

Cited by Christopher R Czajka

1 May 2017
21 CFR 600.80(b)

Review of Adverse Experiences - SOPs

Cited by Anita Narula

1 May 2017
21 CFR 600.80(c)(1)(i)

Reporting Requirements - 15-day alert

Cited by Anita Narula

9 Jun 2015
21 CFR 211.100(b)

Procedure Deviations Recorded and Justified

Cited by Christopher R Czajka, Anita Narula

9 Jun 2015
21 CFR 211.160(a)

Following/documenting laboratory controls

Cited by Christopher R Czajka, Anita Narula

Investigators

FDA investigators tied to this site in the record.

Anita Narula4 insp.
Christopher R Czajka3 insp.
Veronica L Bush1 insp.
Roger F Zabinski1 insp.
Wendy G Tan1 insp.
Jacek Cieslak1 insp.
Kenneth O Gee1 insp.
Mark W Babbitt1 insp.
Sangeeta M Khurana1 insp.
Joshua P Wireman1 insp.
Eric L Dong1 insp.
Barbara J Breithaupt1 insp.
Maria P Kelly-Doggett1 insp.
Mary E Farbman1 insp.
Heika R Tait1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.192Cited across public-safe Form 483 observations3x
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.100(b)Cited across public-safe Form 483 observations1x
21 CFR 211.160(a)Cited across public-safe Form 483 observations1x
21 CFR 211.165(e)Cited across public-safe Form 483 observations1x
21 CFR 211.180(b)Cited across public-safe Form 483 observations1x
21 CFR 211.198(a)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.25(a)Cited across public-safe Form 483 observations1x
21 CFR 312.50Cited across public-safe Form 483 observations1x
21 CFR 314.80(b)Cited across public-safe Form 483 observations1x
21 CFR 314.80(c)(1)(i)Cited across public-safe Form 483 observations1x
21 CFR 600.80(b)Cited across public-safe Form 483 observations1x
21 CFR 600.80(c)(1)(i)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind SEAGEN INC.'s 7 Form 483s

Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat