Overview
- 15 FDA inspections are on record.
- 8 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-05-03.
At a glance
Inspections
15
Form 483s
8
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 25 Apr 2024 – 3 May 2024 | Human Drugs | 483 | On file |
| 8 Aug 2022 – 11 Aug 2022 | Medical Devices & Rad Health | Clean | |
| 27 Jan 2020 – 30 Jan 2020 | Human Drugs | Clean | |
| 17 Jun 2019 – 21 Jun 2019 | Human Drugs | Clean | |
| 10 Jun 2019 – 18 Jun 2019 | Human Drugs | 483 | View 483 → |
| 29 Oct 2018 – 2 Nov 2018 | Human Drugs | Clean | |
| 8 May 2017 – 16 May 2017 | Human Drugs | 483 | On file |
| 5 Aug 2015 – 11 Aug 2015 | Human Drugs | 483 | On file |
| 3 Nov 2014 – 11 Nov 2014 | Human Drugs | 483 | View 483 → |
| 20 Apr 2012 | Not recorded | 483 | View 483 → |
| 22 Oct 2010 | Not recorded | 483 | View 483 → |
| 8 Feb 2008 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
20 Apr 2012
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Bonita S Chester, Melanie M Walker
Investigators
FDA investigators tied to this site in the record.
Adetutu M Gidado1 insp.
Leonard H Lavi1 insp.
Dawn C Olenjack1 insp.
Sripal R Mada1 insp.
Bei Y He1 insp.
Jonathan G Matrisciano1 insp.
Toyin B Oladimeji1 insp.
Michael R Goga1 insp.
Joel D Hustedt1 insp.
Bonita S Chester1 insp.
Melanie M Walker1 insp.
Russell K Riley1 insp.
Kevin A Gonzalez1 insp.
Ginger M Sykes1 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 | 3x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(c)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Novocol Pharmaceutical of Canada, Inc.'s 8 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