Overview
- 15 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-04-18.
At a glance
Inspections
15
Form 483s
3
EIRs
5
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 17 Apr 2023 – 18 Apr 2023 | Biologics | Clean | |
| 27 Mar 2023 – 5 Apr 2023 | Human Drugs | 483 | View 483 → |
| 12 Nov 2019 – 20 Nov 2019 | Human Drugs | 483 | View 483 → |
| 2 Jan 2019 – 7 Jan 2019 | Animal Drugs & Feeds | 483 | View 483 → |
| 4 Jun 2018 | Human Drugs | Clean | |
| 13 Feb 2017 – 22 Feb 2017 | Human Drugs | Clean | |
| 28 Jan 2015 – 3 Feb 2015 | Biologics | Clean | |
| 12 Sep 2013 – 17 Sep 2013 | Biologics | Clean | |
| 23 Jul 2012 | Not recorded | Clean | |
| 14 Jul 2011 | Not recorded | Clean | |
| 24 Jun 2008 | Not recorded | Clean | |
| 9 Dec 2002 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
20 Nov 2019
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by Yvesna C Blaise, Monika Borkowska
20 Nov 2019
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by Yvesna C Blaise, Monika Borkowska
Investigators
FDA investigators tied to this site in the record.
Christina N Maurino2 insp.
Emily A Walters1 insp.
Kristina L Conroy1 insp.
Yvesna C Blaise1 insp.
Monika Borkowska1 insp.
Nancy F Scheraga1 insp.
Helen Verdel1 insp.
Zakaria I Ganiyu1 insp.
Michael R Klapal1 insp.
Alberto A Viciedo1 insp.
Sarah M Forney1 insp.
Denise M Visco1 insp.
Paul L Bellamy1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | 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 Nelson Laboratories Fairfield, Inc.'s 3 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