Overview
- 16 FDA inspections are on record.
- 11 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-05-12.
At a glance
Inspections
16
Form 483s
11
EIRs
5
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 4 May 2026 – 12 May 2026 | Biologics | 483 | View 483 → |
| 19 Aug 2025 – 27 Aug 2025 | Human Drugs | 483 | On file |
| 2 May 2022 – 10 May 2022 | Biologics | 483 | On file |
| 5 Sep 2019 – 13 Sep 2019 | Human Drugs | 483 | On file |
| 8 May 2017 – 16 May 2017 | Biologics | 483 | On file |
| 26 Jan 2015 – 3 Feb 2015 | Human Drugs | 483 | View 483 → |
| 9 Jul 2014 – 18 Jul 2014 | Biologics | 483 | On file |
| 21 Jun 2012 | Not recorded | 483 | On file |
| 19 Oct 2011 | Not recorded | 483 | On file |
| 22 Apr 2010 | Not recorded | 483 | On file |
| 11 Jul 2008 | Not recorded | 483 | On file |
| 7 Apr 2006 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
12 May 2026
21 CFR 211.100(a)
Changes to Procedures Not Reviewed, Approved
Cited by Lewis K Antwi, Yonggang Wang
12 May 2026
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Lewis K Antwi, Yonggang Wang
12 May 2026
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by Lewis K Antwi, Yonggang Wang
12 May 2026
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Lewis K Antwi, Yonggang Wang
12 May 2026
21 CFR 211.22(a)
Authority lacking to review records, investigate errors
Cited by Lewis K Antwi, Yonggang Wang
Investigators
FDA investigators tied to this site in the record.
Debra M Emerson2 insp.
Burnell M Henry2 insp.
Prabhu P Raju2 insp.
Cynthia Jim2 insp.
Lewis K Antwi1 insp.
Yonggang Wang1 insp.
Laurimer Kuilan-Torres1 insp.
Linda Thai1 insp.
Jonathan G Matrisciano1 insp.
Anita R Michael1 insp.
Jacqueline M Diaz Albert1 insp.
Paula A Trost1 insp.
Michael R Goga1 insp.
Gang Wang1 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 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Emergent BioSolutions Canada Inc.'s 11 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