Overview
- 17 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-05-09.
At a glance
Inspections
17
Form 483s
7
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 28 Apr 2025 – 9 May 2025 | Human Drugs | WL | View 483 → |
| 29 Feb 2024 – 8 Mar 2024 | Human Drugs | Clean | |
| 20 Mar 2023 – 24 Mar 2023 | Human Drugs | Clean | |
| 6 Sep 2022 – 14 Sep 2022 | Human Drugs | 483 | On file |
| 20 Jun 2019 – 28 Jun 2019 | Human Drugs | Clean | |
| 18 Mar 2019 – 22 Mar 2019 | Human Drugs | Clean | |
| 3 Apr 2017 – 11 Apr 2017 | Human Drugs | 483 | On file |
| 23 Feb 2015 – 4 Mar 2015 | Human Drugs | Clean | |
| 11 Nov 2014 – 13 Nov 2014 | Human Drugs | Clean | |
| 21 Aug 2013 – 30 Aug 2013 | Human Drugs | 483 | On file |
| 26 Oct 2012 | Not recorded | WL | On file |
| 17 Aug 2010 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
9 May 2025
21 CFR 211.110(a)
Written in-process control procedures
Cited by Justin A Boyd, Wayne D Mcgrath
9 May 2025
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Justin A Boyd, Wayne D Mcgrath
9 May 2025
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Justin A Boyd, Wayne D Mcgrath
9 May 2025
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by Justin A Boyd, Wayne D Mcgrath
Investigators
FDA investigators tied to this site in the record.
Justin A Boyd1 insp.
Wayne D Mcgrath1 insp.
Matthew B Casale1 insp.
Li-Hong P Yeh1 insp.
Yiying E Chen1 insp.
Camerson E Moore1 insp.
Truong X Nguyen1 insp.
Aurora-Miha Trifanov1 insp.
Amanda Lewin1 insp.
Charanjeet Jassal1 insp.
Russell K Riley1 insp.
Karen M Cooper1 insp.
Eileen A Liu1 insp.
Katherine Szestypalow1 insp.
Charisse K Green1 insp.
Sharon K Thoma1 insp.
Steven M Weinman1 insp.
Mark R Mcclain1 insp.
Xikui Chen1 insp.
Barbara D Wright1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 2x |
| 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 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | 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)(vi) | 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 Apotex 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