Overview
- 22 FDA inspections are on record.
- 13 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-04-21.
At a glance
Inspections
22
Form 483s
13
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 7 Apr 2026 – 21 Apr 2026 | Human Drugs | 483 | View 483 → |
| 10 Apr 2024 – 24 Apr 2024 | Human Drugs | 483 | View 483 → |
| 5 Nov 2019 – 15 Nov 2019 | Human Drugs | Clean | |
| 19 Mar 2018 – 11 Apr 2018 | Human Drugs | 483 | View 483 → |
| 8 Feb 2016 – 28 Feb 2016 | Human Drugs | 483 | On file |
| 8 Feb 2016 – 26 Feb 2016 | Human Drugs | 483 | View 483 → |
| 14 Oct 2014 – 29 Oct 2014 | Human Drugs | 483 | View 483 → |
| 29 Mar 2012 | Not recorded | 483 | On file |
| 15 Mar 2011 | Not recorded | WL | View 483 → |
| 29 Oct 2010 | Not recorded | 483 | View 483 → |
| 6 Oct 2010 | Not recorded | 483 | View 483 → |
| 5 Nov 2009 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
21 Apr 2026
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Simone E Pitts, Vivin George, Tanya R Syffrard, Divek R Jumani
21 Apr 2026
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Simone E Pitts, Vivin George, Tanya R Syffrard, Divek R Jumani
21 Apr 2026
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Simone E Pitts, Vivin George, Tanya R Syffrard, Divek R Jumani
21 Apr 2026
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Simone E Pitts, Vivin George, Tanya R Syffrard, Divek R Jumani
21 Apr 2026
21 CFR 211.42(c)(10)(iv)
Environmental Monitoring System
Cited by Simone E Pitts, Vivin George, Tanya R Syffrard, Divek R Jumani
Investigators
FDA investigators tied to this site in the record.
Robert C Horan5 insp.
Kevin A Gonzalez3 insp.
Bijoy Panicker2 insp.
Mindy M Chou2 insp.
Demitria J Xiradakis2 insp.
Simone E Pitts1 insp.
Vivin George1 insp.
Tanya R Syffrard1 insp.
Divek R Jumani1 insp.
Edmund F Mrak1 insp.
Nicholas A Violand1 insp.
Helen B Ricalde1 insp.
Ramon A Hernandez1 insp.
Valerie A Potopsingh1 insp.
Frank Verni1 insp.
Paul C Mouris1 insp.
Juanita P Versace1 insp.
Robert C Steyert1 insp.
Dennis E Guilfoyle1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 7x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.165(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.198(b)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10)(iii) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 11 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 310.305(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(2)(iv)(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(b) | Cited across public-safe Form 483 observations | 1x |
| FDCA 582(g)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind American Regent, Inc.'s 13 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