Overview
- 7 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-09-01.
At a glance
Inspections
7
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 28 Aug 2023 – 1 Sep 2023 | Human Drugs | 483 | On file |
| 14 Jan 2020 – 17 Jan 2020 | Human Drugs | Clean | |
| 4 Dec 2017 – 8 Dec 2017 | Human Drugs | 483 | On file |
| 29 Aug 2016 – 2 Sep 2016 | Human Drugs | Clean | |
| 27 Jan 2014 – 31 Jan 2014 | Human Drugs | Clean | |
| 16 Sep 2011 | Not recorded | 483 | On file |
| 7 Jul 2009 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
1 Sep 2023
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by Bryan L Mcguckin, Michael Araneta
1 Sep 2023
21 CFR 211.208
Salvaging performed without evidence
Cited by Bryan L Mcguckin, Michael Araneta
1 Sep 2023
21 CFR 211.68(a)
Calibration/Inspection/Checking not done
Cited by Bryan L Mcguckin, Michael Araneta
1 Sep 2023
21 CFR 211.68(b)
Computer control of master formula records
Cited by Bryan L Mcguckin, Michael Araneta
8 Dec 2017
21 CFR 211.160(b)(4)
Instruments, apparatus, et. al. not meeting specs
Cited by Doan T Nguyen
Investigators
FDA investigators tied to this site in the record.
Bryan L Mcguckin1 insp.
Michael Araneta1 insp.
Samina S Khan1 insp.
Doan T Nguyen1 insp.
Saied A Asbagh1 insp.
Yumi J Hiramine1 insp.
Eric M Mueller1 insp.
Erin D Mccaffery1 insp.
Mei-Chiung J Huang1 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 | 1x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.208 | 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 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Delpharm Montreal Inc.'s 3 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