Overview
- 8 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-05-15.
At a glance
Inspections
8
Form 483s
3
EIRs
1
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 May 2025 – 15 May 2025 | Biologics | Clean | |
| 10 Aug 2021 – 30 Aug 2021 | Biologics | 483 | View 483 → |
| 9 Sep 2019 – 23 Sep 2019 | Biologics | 483 | View 483 → |
| 10 Jan 2017 – 12 Jan 2017 | Biologics | Clean | |
| 23 Mar 2015 – 26 Mar 2015 | Biologics | Clean | |
| 10 Jun 2013 – 19 Jun 2013 | Biologics | 483 | View 483 → |
| 10 Aug 2011 | Not recorded | Clean | |
| 17 Jun 2010 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
23 Sep 2019
21 CFR 1271.160(b)(1)
Ensuring appropriate core requirements followed
Cited by Shavon L Square, Amanda B Athey, Amanda B Vega
23 Sep 2019
21 CFR 1271.160(b)(1)
Ensuring appropriate core requirements followed
Cited by Shavon L Square, Amanda B Athey, Amanda B Vega
23 Sep 2019
21 CFR 1271.80(c)
Manufacturer instructions not followed
Cited by Shavon L Square, Amanda B Athey, Amanda B Vega
Investigators
FDA investigators tied to this site in the record.
La-Tasha M Gunter3 insp.
Margaret Torres-Vazquez2 insp.
Chanel E Crawford1 insp.
Shavon L Square1 insp.
Amanda B Athey1 insp.
Amanda B Vega1 insp.
Brandon L Mariner1 insp.
Laurie A Haxel1 insp.
Sherry L Secrist1 insp.
Tania E Vizcaino1 insp.
Linda S Mattingly1 insp.
Tamika E Allen1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.80(c) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 1271.160(b)(1) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 1271.160(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.200(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.270(d) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Quest Diagnostics Nichols Institute'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