Overview
- 1 FDA inspection is on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2025-11-04.
At a glance
Inspections
1
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 29 Oct 2025 – 4 Nov 2025 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
4 Nov 2025
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Anthony J Donato, Jessica S Estriplet
4 Nov 2025
21 CFR 211.142(b)
Storage under appropriate conditions
Cited by Anthony J Donato, Jessica S Estriplet
4 Nov 2025
21 CFR 211.180(e)(1)
Review of representative number of batches
Cited by Anthony J Donato, Jessica S Estriplet
4 Nov 2025
21 CFR 211.186(b)(9)
Complete instructions, procedures, specifications et. al.
Cited by Anthony J Donato, Jessica S Estriplet
Investigators
FDA investigators tied to this site in the record.
Anthony J Donato1 insp.
Jessica S Estriplet1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.137(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Leading Edge Innovations, LLC's 1 Form 483
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