Overview
- 8 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-06-05.
At a glance
Inspections
8
Form 483s
5
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 28 May 2025 – 5 Jun 2025 | Biologics | 483 | View 483 → |
| 1 Jun 2022 – 9 Jun 2022 | Biologics | 483 | On file |
| 11 Jun 2018 – 18 Jun 2018 | Biologics | 483 | On file |
| 10 May 2016 – 17 May 2016 | Biologics | 483 | On file |
| 3 Feb 2014 – 12 Feb 2014 | Biologics | 483 | On file |
| 19 Nov 2013 – 21 Nov 2013 | Human Drugs | Clean | |
| 20 Apr 2012 | Not recorded | Clean | |
| 21 May 2010 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
5 Jun 2025
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Thai D Truong, Laurel A Beer
Investigators
FDA investigators tied to this site in the record.
Thai D Truong1 insp.
Laurel A Beer1 insp.
Susan M Jackson1 insp.
Jeremy L Wally1 insp.
Priscilla M Pastrana1 insp.
Simone E Pitts1 insp.
Haruhiko Murata1 insp.
Gene D Arcy1 insp.
Prabhu P Raju1 insp.
Robert D Tollefsen1 insp.
Anthony F Lorenzo1 insp.
Michael J Vardon1 insp.
Penny H Mccarver1 insp.
Pankaj H Amin1 insp.
Randa Melhem1 insp.
Pamela L Vega1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Seqirus Inc's 5 Form 483s
Source PDFs 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