Overview
- 4 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-11-01.
At a glance
Inspections
4
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 21 Oct 2024 – 1 Nov 2024 | Medical Devices & Rad Health | 483 | View 483 → |
| 11 May 2023 – 24 May 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 1 May 2023 – 4 May 2023 | Medical Devices & Rad Health | Clean | |
| 3 Jun 2021 – 8 Jun 2021 | Medical Devices & Rad Health | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
1 Nov 2024
21 CFR 820.30(g)
Design Validation - Risk analysis not performed/inadequate
Cited by Christine I Shaw
1 Nov 2024
21 CFR 820.30(g)
Design validation - software validation not performed
Cited by Christine I Shaw
Investigators
FDA investigators tied to this site in the record.
Christine I Shaw2 insp.
Ruth A Williams2 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.181 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(j) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind HepQuant, LLC's 2 Form 483s
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