Overview
- 10 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-01-26.
At a glance
Inspections
10
Form 483s
4
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 18 Jan 2024 – 26 Jan 2024 | Human Drugs | 483 | View 483 → |
| 3 Feb 2020 – 11 Feb 2020 | Human Drugs | Clean | |
| 4 Jun 2018 – 12 Jun 2018 | Human Drugs | Clean | |
| 1 Aug 2016 – 9 Aug 2016 | Human Drugs | Clean | |
| 15 Oct 2013 – 22 Oct 2013 | Human Drugs | 483 | View 483 → |
| 4 Aug 2011 | Not recorded | 483 | On file |
| 15 Jul 2009 | Not recorded | 483 | View 483 → |
| 28 Sep 2006 | Not recorded | Clean | |
| 19 Dec 2002 | Not recorded | Clean | |
| 28 Jan 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
22 Oct 2013
21 CFR 211.68(a)
Calibration/Inspection/Checking not done
Cited by Ileana Barreto-Pettit, Juanita P Versace, Karen E Dorazio
Investigators
FDA investigators tied to this site in the record.
Edmund F Mrak1 insp.
Sarah E Rhoades1 insp.
Brett R Havranek1 insp.
Steven D Kehoe1 insp.
Ileana Barreto-Pettit1 insp.
Juanita P Versace1 insp.
Karen E Dorazio1 insp.
Sharon K Thoma1 insp.
Barbara J Breithaupt1 insp.
Sarah E Mcmullen1 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 | 2x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.186(b)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(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(c)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.86 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Delpharm Boucherville 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