Overview
- 14 FDA inspections are on record.
- 8 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-07-31.
At a glance
Inspections
14
Form 483s
8
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 28 Jul 2025 – 31 Jul 2025 | Human Drugs | Clean | |
| 19 Sep 2022 – 23 Sep 2022 | Human Drugs | Clean | |
| 10 Jun 2019 – 19 Jun 2019 | Human Drugs | Clean | |
| 7 May 2018 – 10 May 2018 | Human Drugs | Clean | |
| 5 Jun 2017 – 14 Jun 2017 | Human Drugs | 483 | View 483 → |
| 15 Aug 2016 – 19 Aug 2016 | Human Drugs | 483 | View 483 → |
| 12 May 2015 – 15 May 2015 | Human Drugs | 483 | On file |
| 4 May 2015 – 11 May 2015 | Human Drugs | 483 | On file |
| 12 Aug 2013 – 20 Aug 2013 | Human Drugs | 483 | View 483 → |
| 24 Aug 2012 | Not recorded | 483 | View 483 → |
| 11 Feb 2011 | Not recorded | 483 | On file |
| 14 Aug 2009 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Susanne M Richardson2 insp.
Anthony J Grace1 insp.
Marian E Ramirez1 insp.
Truong X Nguyen1 insp.
Aurora-Miha Trifanov1 insp.
Matthew C Watson1 insp.
Laurimer Kuilan-Torres1 insp.
Hala L Selby1 insp.
Djamila Harouaka1 insp.
Eileen A Liu1 insp.
Katherine Szestypalow1 insp.
Charisse K Green1 insp.
Parul M Patel1 insp.
S. L Brown1 insp.
Francis A Guidry1 insp.
Steven M Weinman1 insp.
Michael R Goga1 insp.
Sarah E Mcmullen1 insp.
Walden H Lee1 insp.
Lloyd D Payne1 insp.
Kristy A Zielny1 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 | 3x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(b)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.103 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.122(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.125(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.137(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.46(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(3) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Apotex Inc.'s 8 Form 483s
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