Overview
- 6 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-01-16.
At a glance
Inspections
6
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 Jan 2025 – 16 Jan 2025 | Human Drugs | Clean | |
| 9 May 2022 – 13 May 2022 | Human Drugs | 483 | View 483 → |
| 27 Nov 2018 – 4 Dec 2018 | Medical Devices & Rad Health | 483 | View 483 → |
| 21 Dec 2015 – 21 Jan 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 6 Sep 2012 | Not recorded | Clean | |
| 14 Jul 2009 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
13 May 2022
21 CFR 820.30(i)
Design changes - Lack of or Inadequate Procedures
Cited by Brian D Nicholson
Investigators
FDA investigators tied to this site in the record.
Susan M Matthias2 insp.
Melissa M Steiger1 insp.
Elizabeth R Bloom1 insp.
Brian D Nicholson1 insp.
Benjamin W Anderson1 insp.
James A Beaulieu1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 806.10(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Antares Pharma, 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