Overview
- 25 FDA inspections are on record.
- 11 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-05-07.
At a glance
Inspections
25
Form 483s
11
EIRs
7
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 29 Apr 2025 – 7 May 2025 | Biologics | 483 | View 483 → |
| 21 Aug 2023 – 30 Aug 2023 | Biologics | 483 | View 483 → |
| 10 Feb 2020 – 14 Feb 2020 | Human Drugs | Clean | |
| 19 Aug 2019 – 5 Sep 2019 | Biologics | Clean | |
| 20 Aug 2018 – 24 Aug 2018 | Human Drugs | Clean | |
| 13 Aug 2018 – 17 Aug 2018 | Human Drugs | 483 | View 483 → |
| 4 Apr 2016 – 8 Apr 2016 | Animal Drugs & Feeds | 483 | View 483 → |
| 13 Apr 2015 – 16 Apr 2015 | Human Drugs | Clean | |
| 21 Oct 2014 – 3 Nov 2014 | Human Drugs | 483 | On file |
| 14 Feb 2014 – 20 Feb 2014 | Human Drugs | 483 | On file |
| 11 Feb 2013 – 14 Feb 2013 | Human Drugs | 483 | On file |
| 28 Nov 2012 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
30 Aug 2023
21 CFR 58.190(a)
Archives: data, documentation, specimens
Cited by Denise L Burosh, Dina A Tallman
30 Aug 2023
21 CFR 58.33(a)
Study director: follow study protocol
Cited by Denise L Burosh, Dina A Tallman
30 Aug 2023
21 CFR 58.90(g)
Animal care: analysis of feed and water
Cited by Denise L Burosh, Dina A Tallman
Investigators
FDA investigators tied to this site in the record.
Denise L Burosh7 insp.
Scott B Laufenberg5 insp.
Corey K Reno4 insp.
Charles Cote3 insp.
Carmen Y Fisher1 insp.
Dina A Tallman1 insp.
Xiaohan Cai1 insp.
Kara A Scheibner1 insp.
Zhou Chen1 insp.
Jasjeet K Sekhon1 insp.
Sandra A Hughes1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 58.120(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.190(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.33(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.33(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.45 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.63(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.81(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.90(g) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Labcorp Early Development Laboratories, Inc.'s 11 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