Overview
- 19 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-07-25.
At a glance
Inspections
19
Form 483s
5
EIRs
4
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 21 Jul 2025 – 25 Jul 2025 | Human Drugs | 483 | View 483 → |
| 7 Apr 2025 – 11 Apr 2025 | Human Drugs | 483 | View 483 → |
| 8 Jul 2024 – 12 Jul 2024 | Human Drugs | 483 | View 483 → |
| 8 Aug 2022 – 12 Aug 2022 | Human Drugs | 483 | View 483 → |
| 9 Mar 2020 – 13 Mar 2020 | Biologics | Clean | |
| 20 Nov 2019 – 21 Nov 2019 | Human Drugs | Clean | |
| 19 Jan 2016 – 20 Jan 2016 | Human Drugs | Clean | |
| 2 Jun 2014 – 6 Jun 2014 | Human Drugs | 483 | On file |
| 12 Nov 2013 – 13 Nov 2013 | Human Drugs | Clean | |
| 5 Aug 2008 | Not recorded | Clean | |
| 4 Aug 2008 | Not recorded | Clean | |
| 19 Sep 2002 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
25 Jul 2025
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Melissa M Steiger, Shannon L Maisano
25 Jul 2025
21 CFR 211.166(a)(4)
Testing in same container - closure system
Cited by Melissa M Steiger, Shannon L Maisano
25 Jul 2025
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Melissa M Steiger, Shannon L Maisano
25 Jul 2025
21 CFR 211.68(b)
Computer control of master formula records
Cited by Melissa M Steiger, Shannon L Maisano
11 Apr 2025
21 CFR 58.33(b)
Study director: all data recorded and verified
Cited by Corrine M Carter, Chelsea W Lamm
Investigators
FDA investigators tied to this site in the record.
Corrine M Carter3 insp.
Larry K Austin3 insp.
Chelsea W Lamm2 insp.
Melissa M Steiger1 insp.
Shannon L Maisano1 insp.
Dina A Tallman1 insp.
Lynda L Lanning1 insp.
Constantin Y Philopoulos1 insp.
Robert M Barbosa1 insp.
Meisha R Sampson1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 58.81(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 58.35(b)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.107 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.185(a)(10) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.29(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.33(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.33(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.33(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.35(b)(5) | 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(b) | 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