Overview
- 12 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-08-01.
At a glance
Inspections
12
Form 483s
5
EIRs
5
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 24 Jul 2023 – 1 Aug 2023 | Human Drugs | Clean | |
| 6 Aug 2020 – 14 Aug 2020 | Human Drugs | Clean | |
| 18 Sep 2017 – 27 Sep 2017 | Human Drugs | 483 | View 483 → |
| 3 Nov 2016 – 30 Nov 2016 | Animal Drugs & Feeds | 483 | View 483 → |
| 22 Aug 2014 – 12 Sep 2014 | Human Drugs | 483 | On file |
| 28 Jan 2011 | Not recorded | 483 | On file |
| 22 Dec 2008 | Not recorded | 483 | On file |
| 23 Aug 2007 | Not recorded | Clean | |
| 6 May 2005 | Not recorded | Clean | |
| 6 Aug 2003 | Not recorded | Clean | |
| 9 Oct 2002 | Not recorded | Clean | |
| 13 Aug 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
27 Sep 2017
21 CFR 58.35(b)(5)
QAU: authorize deviations from protocols or SOPs
Cited by Peter R Lenahan
Investigators
FDA investigators tied to this site in the record.
Denise M Visco3 insp.
Peter R Lenahan2 insp.
Dawn L Wydner2 insp.
Michael Serrano1 insp.
Tyanna N Hadley1 insp.
Mayar M Mussa1 insp.
Anastasia I Offordile1 insp.
Byungja E Marciante1 insp.
Michael R Klapal1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 58.130(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 58.35(b)(5) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 58.185(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 58.35(b)(6) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 58.113(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.185(a)(10) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.185(a)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.31(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.33(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.81(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Labcorp Early Development Laboratories, Inc.'s 5 Form 483s
Source PDFs 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