Overview
- 10 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-03-05.
At a glance
Inspections
10
Form 483s
4
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 2 Mar 2026 – 5 Mar 2026 | Human Drugs | 483 | View 483 → |
| 18 Nov 2021 – 19 Nov 2021 | Human Drugs | Clean | |
| 6 Jan 2020 – 8 Jan 2020 | Human Drugs | Clean | |
| 15 Nov 2017 | Human Drugs | Clean | |
| 6 Mar 2017 – 9 Mar 2017 | Human Drugs | Clean | |
| 5 Aug 2014 – 8 Aug 2014 | Human Drugs | 483 | On file |
| 10 Apr 2013 – 11 Apr 2013 | Human Drugs | Clean | |
| 7 Feb 2012 | Not recorded | 483 | On file |
| 26 Jun 2009 | Not recorded | 483 | On file |
| 22 Aug 2008 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Andrew J Barrowcliff3 insp.
Dell S Moller3 insp.
Lisa R Hilliard1 insp.
Kenneth E Felkley1 insp.
Nicholas L Paulin1 insp.
Ucheabuchi C Chudi-Nwankwor1 insp.
Christopher T Middendorf1 insp.
Michael E Clark1 insp.
Phillip M Pontikos1 insp.
Andria L Kuhlman1 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 | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind American Regent, Inc.'s 4 Form 483s
Source PDFs 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