Overview
- 3 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2023-02-01.
At a glance
Inspections
3
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 30 Jan 2023 – 1 Feb 2023 | Medical Devices & Rad Health | Clean | |
| 21 Jul 2021 – 23 Jul 2021 | Medical Devices & Rad Health | 483 | View 483 → |
| 3 Oct 2018 | Medical Devices & Rad Health | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
23 Jul 2021
21 CFR 820.30(g)
Design validation- Lack of or inadequate procedures
Cited by Rosanna M Goodrich
23 Jul 2021
21 CFR 820.30(h)
Design transfer - Lack of or inadequate procedures
Cited by Rosanna M Goodrich
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(h) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Bryan Medical Inc'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