Overview
- 14 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2016-03-18.
At a glance
Inspections
14
Form 483s
7
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 25 Feb 2016 – 18 Mar 2016 | Human Drugs | 483 | View 483 → |
| 10 Nov 2014 – 26 Nov 2014 | Human Drugs | 483 | View 483 → |
| 22 Jan 2013 – 21 Feb 2013 | Human Drugs | 483 | View 483 → |
| 12 Oct 2012 | Not recorded | 483 | View 483 → |
| 14 Feb 2012 | Not recorded | 483 | View 483 → |
| 20 Sep 2011 | Not recorded | Clean | |
| 22 Jun 2010 | Not recorded | 483 | View 483 → |
| 15 Apr 2010 | Not recorded | Clean | |
| 3 Dec 2008 | Not recorded | Clean | |
| 16 Jul 2008 | Not recorded | 483 | On file |
| 1 Oct 2007 | Not recorded | Clean | |
| 18 May 2005 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
18 Mar 2016
21 CFR 314.80(b)
Failure to develop written procedures
Cited by Nancy F Scheraga, Liatte Krueger
18 Mar 2016
21 CFR 314.80(c)(1)(i)
Late submission of 15-day report
Cited by Nancy F Scheraga, Liatte Krueger
18 Mar 2016
21 CFR 314.80(c)(1)(i)
Late submission of 15-day report
Cited by Nancy F Scheraga, Liatte Krueger
18 Mar 2016
21 CFR 314.80(c)(1)(ii)
Failure to investigate serious, unexpected events
Cited by Nancy F Scheraga, Liatte Krueger
18 Mar 2016
21 CFR 314.80(c)(1)(ii)
Failure to investigate serious, unexpected events
Cited by Nancy F Scheraga, Liatte Krueger
Investigators
FDA investigators tied to this site in the record.
Peter R Lenahan4 insp.
Nancy F Scheraga1 insp.
Liatte Krueger1 insp.
Christina N Maurino1 insp.
Michael Serrano1 insp.
Jonee J Mearns1 insp.
Krystal O Ogunremi1 insp.
Dawn L Wydner1 insp.
Allen Lou1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 312.50 | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 314.80(c)(1)(i) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 314.80(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 314.80(c)(1)(ii) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 312.53(c)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 312.57(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 812.40 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Forest Research Institute, Inc.'s 7 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