Overview
- 5 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-02-07.
At a glance
Inspections
5
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 3 Feb 2025 – 7 Feb 2025 | Human Drugs | 483 | View 483 → |
| 15 Jul 2024 – 18 Jul 2024 | Medical Devices & Rad Health | Clean | |
| 13 Jan 2020 – 17 Jan 2020 | Human Drugs | 483 | View 483 → |
| 4 Dec 2017 – 8 Dec 2017 | Human Drugs | 483 | View 483 → |
| 22 Feb 2016 – 26 Feb 2016 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
7 Feb 2025
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Wen Ning Chan, WenNing Chan
7 Feb 2025
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Wen Ning Chan, WenNing Chan
17 Jan 2020
21 CFR 211.170(b)
Annual visual exams of drug products
Cited by Ucheabuchi C Chudi-Nwankwor
17 Jan 2020
21 CFR 211.182
Written records kept in individual logs
Cited by Ucheabuchi C Chudi-Nwankwor
17 Jan 2020
21 CFR 211.186(a)
Master production and control records, procedure
Cited by Ucheabuchi C Chudi-Nwankwor
Investigators
FDA investigators tied to this site in the record.
Wen Ning Chan1 insp.
WenNing Chan1 insp.
Inga M Warr1 insp.
Ucheabuchi C Chudi-Nwankwor1 insp.
Erik W Koester1 insp.
Yumi J Hiramine1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.182 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Church & Dwight Canada Corp's 4 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