Overview
- 8 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-02-17.
At a glance
Inspections
8
Form 483s
6
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 Feb 2023 – 17 Feb 2023 | Human Drugs | 483 | View 483 → |
| 3 Jun 2019 – 7 Jun 2019 | Human Drugs | 483 | On file |
| 5 Dec 2016 – 9 Dec 2016 | Human Drugs | 483 | View 483 → |
| 26 Feb 2015 – 27 Feb 2015 | Human Drugs | 483 | View 483 → |
| 20 Jan 2014 – 24 Jan 2014 | Human Drugs | 483 | On file |
| 18 Dec 2009 | Not recorded | 483 | View 483 → |
| 30 Mar 2007 | Not recorded | Clean | |
| 20 Jul 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
17 Feb 2023
21 CFR 211.111
Deviations of production time limits
Cited by Sena G Dissmeyer, Brandy N Lepage
17 Feb 2023
21 CFR 211.22(a)
Approve or reject components, products
Cited by Sena G Dissmeyer, Brandy N Lepage
17 Feb 2023
21 CFR 211.42(c)
Defined areas of adequate size for operations
Cited by Sena G Dissmeyer, Brandy N Lepage
17 Feb 2023
21 CFR 211.67(a)
Cleaning / Sanitizing / Maintenance
Cited by Sena G Dissmeyer, Brandy N Lepage
Investigators
FDA investigators tied to this site in the record.
Sena G Dissmeyer1 insp.
Brandy N Lepage1 insp.
Qin Xu1 insp.
Ivy E Sweeney1 insp.
Anh Lac1 insp.
Yumi J Hiramine1 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 211.166(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.111 | Cited across public-safe Form 483 observations | 1x |
| 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 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(10) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(11) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c) | 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 |
| FDCA 760(b)(1) | Cited across public-safe Form 483 observations | 1x |
| FDCA 760(c)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind ANI Pharmaceuticals Canada, Inc.'s 6 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