Overview
- 7 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-05-09.
At a glance
Inspections
7
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 5 May 2025 – 9 May 2025 | Human Drugs | 483 | View 483 → |
| 16 Jan 2018 – 25 Jan 2018 | Human Drugs | 483 | View 483 → |
| 21 Dec 2015 – 19 Jan 2016 | Human Drugs | 483 | View 483 → |
| 6 May 2013 – 9 May 2013 | Human Drugs | 483 | View 483 → |
| 25 Mar 2008 | Not recorded | 483 | On file |
| 21 Feb 2007 | Not recorded | Clean | |
| 7 Jun 2005 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
9 May 2025
21 CFR 212.20(e)
Written QA procedures established, followed
Cited by Tanya R Syffrard, Karishma G Gopaul
9 May 2025
21 CFR 212.60(g)
Test records complete (general)
Cited by Tanya R Syffrard, Karishma G Gopaul
Investigators
FDA investigators tied to this site in the record.
Robert C Steyert3 insp.
Tanya R Syffrard1 insp.
Karishma G Gopaul1 insp.
Mindy M Chou1 insp.
Vioela J Caze1 insp.
Kenneth H Williams1 insp.
Valentino Fiorella1 insp.
Xiaokuang Lai1 insp.
Paul C Mouris1 insp.
Gary J Lehr1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 212.70(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 212.20(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 212.20(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 212.60(g)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 212.70(f)(1)(vi) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.30(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.40(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.50 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.60(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.60(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.60(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.60(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.70(d)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.71(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind The Feinstein Institute for Medical Research'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