Overview
- 10 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-12-12.
At a glance
Inspections
10
Form 483s
6
EIRs
5
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 8 Dec 2025 – 12 Dec 2025 | Human Drugs | Clean | |
| 4 Feb 2025 – 19 Feb 2025 | Human Drugs | 483 | View 483 → |
| 2 Feb 2023 – 2 Mar 2023 | Human Drugs | WL | View 483 → |
| 14 Feb 2022 – 24 Feb 2022 | Human Drugs | 483 | View 483 → |
| 8 Jan 2020 – 15 Jan 2020 | Human Drugs | 483 | View 483 → |
| 22 Jul 2019 – 26 Jul 2019 | Human Drugs | Clean | |
| 11 Dec 2017 – 20 Dec 2017 | Human Drugs | Clean | |
| 5 Apr 2016 – 19 Apr 2016 | Human Drugs | Clean | |
| 2 Jan 2014 – 29 Jan 2014 | Human Drugs | 483 | On file |
| 19 Mar 2010 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
19 Feb 2025
21 CFR 211.198(a)
Complaint Handling Procedure
Cited by Erik W Koester, Armen H Youssoufian
Investigators
FDA investigators tied to this site in the record.
Erik W Koester4 insp.
Armen H Youssoufian2 insp.
John P Mistler2 insp.
Robert J Martin1 insp.
Terry Bridgewater1 insp.
Tonia F Bernard1 insp.
Christopher Janik1 insp.
Dien N Nguyen1 insp.
Mary-Jeanet Mcgarry1 insp.
Justine M Corson1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(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(b)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(c)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Azurity Pharmaceuticals, 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