Overview
- 7 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-11-15.
At a glance
Inspections
7
Form 483s
4
EIRs
2
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 Nov 2023 – 15 Nov 2023 | Human Drugs | Clean | |
| 15 Oct 2019 – 16 Oct 2019 | Human Drugs | Clean | |
| 11 Dec 2017 – 12 Dec 2017 | Human Drugs | 483 | View 483 → |
| 15 Sep 2016 – 16 Sep 2016 | Human Drugs | 483 | On file |
| 19 Jun 2014 – 20 Jun 2014 | Human Drugs | Clean | |
| 20 Jul 2012 | Not recorded | 483 | On file |
| 10 Dec 2009 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
10 Dec 2009
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Debra M Emerson, Sarah E Mcmullen
10 Dec 2009
21 CFR 211.63
Equipment Design, Size and Location
Cited by Debra M Emerson, Sarah E Mcmullen
Investigators
FDA investigators tied to this site in the record.
Libia M Lugo1 insp.
Edmund F Mrak1 insp.
Doan T Nguyen1 insp.
Kham Phommachanh1 insp.
Eileen A Liu1 insp.
Nebil A Oumer1 insp.
Michael R Klapal1 insp.
Debra M Emerson1 insp.
Sarah E Mcmullen1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(4) | 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 211.63 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind SGS Canada Inc's 4 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