Overview
- 11 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-07-30.
At a glance
Inspections
11
Form 483s
5
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 30 Jul 2024 | Biologics | Clean | |
| 11 Sep 2018 – 13 Sep 2018 | Biologics | Clean | |
| 22 Aug 2016 – 25 Aug 2016 | Biologics | 483 | View 483 → |
| 22 Jul 2014 – 28 Jul 2014 | Biologics | 483 | View 483 → |
| 18 Sep 2012 | Not recorded | 483 | View 483 → |
| 22 Sep 2010 | Not recorded | 483 | View 483 → |
| 30 Sep 2009 | Not recorded | 483 | View 483 → |
| 14 Jun 2006 | Not recorded | Clean | |
| 3 Dec 2003 | Not recorded | Clean | |
| 10 Oct 2001 | Not recorded | Clean | |
| 1 Dec 1999 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
25 Aug 2016
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Travis S Bradley, Brittany M Lowe
28 Jul 2014
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Ifueko Osemwota
18 Sep 2012
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Dawn C Olenjack
18 Sep 2012
21 CFR 606.100(b)(15)
Schedules and procedures for equipment & calibration
Cited by Dawn C Olenjack
Investigators
FDA investigators tied to this site in the record.
Kimberly Y Martin2 insp.
Lesley Mae P Lutao1 insp.
Erma Zaimova1 insp.
Travis S Bradley1 insp.
Brittany M Lowe1 insp.
Ifueko Osemwota1 insp.
Dawn C Olenjack1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 606.100(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 606.160(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 600.10(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.100(b)(12) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.100(b)(15) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.171 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.20(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.60(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.65(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Quest Diagnostics' 5 Form 483s
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