Overview
- 9 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-01-22.
At a glance
Inspections
9
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 20 Jan 2025 – 22 Jan 2025 | Human Drugs | 483 | On file |
| 17 Oct 2019 – 18 Oct 2019 | Human Drugs | 483 | View 483 → |
| 11 Sep 2017 – 15 Sep 2017 | Human Drugs | 483 | On file |
| 5 Feb 2015 – 9 Feb 2015 | Human Drugs | 483 | View 483 → |
| 6 Dec 2012 | Not recorded | 483 | On file |
| 29 Jul 2009 | Not recorded | Clean | |
| 12 May 2006 | Not recorded | Clean | |
| 17 Sep 2002 | Not recorded | Clean | |
| 15 Oct 1999 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
9 Feb 2015
21 CFR 211.22(a)
Authority lacking to review records, investigate errors
Cited by Anita R Michael
Investigators
FDA investigators tied to this site in the record.
Michael A Charles1 insp.
Edmund F Mrak1 insp.
Adetutu M Gidado1 insp.
Anita R Michael1 insp.
Brian D Nicholson1 insp.
Denise M Digiulio1 insp.
Sixto M Mercado Rios1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.194(a)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Element Materials Technology Canada Inc.'s 5 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