Overview
- 4 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-05-02.
At a glance
Inspections
4
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 28 Apr 2025 – 2 May 2025 | Human Drugs | 483 | View 483 → |
| 8 Apr 2019 – 12 Apr 2019 | Human Drugs | 483 | On file |
| 3 Nov 2014 – 7 Nov 2014 | Human Drugs | Clean | |
| 21 Sep 2011 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
2 May 2025
21 CFR 211.186(b)(9)
Complete instructions, procedures, specifications et. al.
Cited by Sean R Marcsisin
Investigators
FDA investigators tied to this site in the record.
Sean R Marcsisin1 insp.
Ucheabuchi C Chudi-Nwankwor1 insp.
Yubing Tang1 insp.
Charles D Brown1 insp.
Robert J Martin1 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 211.186(b)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Catalent Ontario Limited's 3 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