Overview
- 7 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-01-29.
At a glance
Inspections
7
Form 483s
5
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 20 Jan 2026 – 29 Jan 2026 | Human Drugs | 483 | View 483 → |
| 5 Dec 2022 – 9 Dec 2022 | Human Drugs | 483 | On file |
| 22 Sep 2022 – 30 Sep 2022 | Human Drugs | 483 | View 483 → |
| 29 Oct 2018 – 6 Nov 2018 | Human Drugs | Clean | |
| 24 Oct 2016 – 28 Oct 2016 | Human Drugs | Clean | |
| 2 May 2016 – 5 May 2016 | Human Drugs | 483 | View 483 → |
| 9 Mar 2015 – 19 Mar 2015 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
29 Jan 2026
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Martin M Kimani, Logan T Williams, Nelson N Ayangho
29 Jan 2026
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Martin M Kimani, Logan T Williams, Nelson N Ayangho
29 Jan 2026
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Martin M Kimani, Logan T Williams, Nelson N Ayangho
29 Jan 2026
21 CFR 211.84(e)
Rejecting When Specifications Not Met
Cited by Martin M Kimani, Logan T Williams, Nelson N Ayangho
Investigators
FDA investigators tied to this site in the record.
Nicholas L Paulin3 insp.
Andrew J Barrowcliff2 insp.
Martin M Kimani1 insp.
Logan T Williams1 insp.
Nelson N Ayangho1 insp.
Robert J Ham1 insp.
Joohi Castelvetere1 insp.
Christopher T Middendorf1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.165(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(e) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind American Regent, Inc.'s 5 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