Overview
- 22 FDA inspections are on record.
- 9 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-09-26.
At a glance
Inspections
22
Form 483s
9
EIRs
7
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 22 Sep 2025 – 26 Sep 2025 | Human Drugs | 483 | View 483 → |
| 20 Jul 2023 – 24 Jul 2023 | Human Drugs | Clean | |
| 18 Apr 2023 – 21 Apr 2023 | Human Drugs | Clean | |
| 7 Jan 2020 – 14 Jan 2020 | Human Drugs | Clean | |
| 9 Dec 2019 – 13 Dec 2019 | Human Drugs | 483 | View 483 → |
| 11 Feb 2019 – 15 Feb 2019 | Human Drugs | 483 | View 483 → |
| 5 Feb 2018 – 14 Feb 2018 | Human Drugs | 483 | View 483 → |
| 24 Feb 2017 – 2 Mar 2017 | Human Drugs | 483 | View 483 → |
| 1 Mar 2016 – 11 Mar 2016 | Human Drugs | 483 | View 483 → |
| 17 Aug 2015 – 21 Aug 2015 | Human Drugs | 483 | View 483 → |
| 20 Oct 2014 – 30 Oct 2014 | Human Drugs | Clean | |
| 17 Jun 2014 – 18 Jun 2014 | Human Drugs | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
26 Sep 2025
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Paranthaman SenthamaraiKannan, WenNing Chan
26 Sep 2025
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Paranthaman SenthamaraiKannan, WenNing Chan
26 Sep 2025
21 CFR 211.67(b)
Written procedures not established/followed
Cited by Paranthaman SenthamaraiKannan, WenNing Chan
13 Dec 2019
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Lauren N Howard, Jon P Antoniou, Byeongtaek Oh
13 Dec 2019
21 CFR 211.110(b)
In-process materials specifications
Cited by Lauren N Howard, Jon P Antoniou, Byeongtaek Oh
Investigators
FDA investigators tied to this site in the record.
Anna M Brannen5 insp.
Lindsey M Schwierjohann4 insp.
Christopher T Middendorf3 insp.
Elizabeth L Edwards3 insp.
Logan T Williams2 insp.
Wen Ning Chan2 insp.
Lauren N Howard2 insp.
Jon P Antoniou2 insp.
Kenneth E Felkley2 insp.
Nicholas L Paulin2 insp.
Tracey L Harris2 insp.
Michael P Sheehan2 insp.
Marianne Allen2 insp.
WenNing Chan1 insp.
Byeongtaek Oh1 insp.
Ying Zhang1 insp.
Lindsey S Fleischman1 insp.
Lauren N Smith1 insp.
Joshua P Wireman1 insp.
Cynthia T Cain1 insp.
Thomas J Arista1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | 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 Patheon Pharmaceuticals Inc.'s 9 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