Overview
- 4 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-11-20.
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 |
|---|---|---|---|
| 19 Nov 2025 – 20 Nov 2025 | Medical Devices & Rad Health | 483 | View 483 → |
| 7 Jul 2021 – 8 Jul 2021 | Medical Devices & Rad Health | Clean | |
| 1 Apr 2019 – 2 Apr 2019 | Medical Devices & Rad Health | Clean | |
| 16 Sep 2015 – 18 Sep 2015 | Medical Devices & Rad Health | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
20 Nov 2025
21 CFR 820.30(g)
Design Validation - Risk analysis not performed/inadequate
Cited by Tyler R Courtney
20 Nov 2025
21 CFR 820.30(g)
Design Validation - Risk analysis not performed/inadequate
Cited by Tyler R Courtney
18 Sep 2015
21 CFR 820.30(g)
Design Validation - Risk analysis not performed/inadequate
Cited by Benjamin W Anderson
Investigators
FDA investigators tied to this site in the record.
Tyler R Courtney1 insp.
Christina L Bigham1 insp.
Marissa S Steinhagen1 insp.
Benjamin W Anderson1 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 | 1x |
Full site report
Get the verbatim findings behind Reprise Biomedical, Inc.'s 2 Form 483s
Source PDFs, verbatim observations, 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