Overview
- 2 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2026-03-25.
At a glance
Inspections
2
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 20 Mar 2026 – 25 Mar 2026 | Medical Devices & Rad Health | Clean | |
| 28 Feb 2022 – 10 Mar 2022 | Medical Devices & Rad Health | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
10 Mar 2022
21 CFR 820.250(a)
Statistical techniques - Lack of or inadequate procedures
Cited by Richard T Riggie, Jocelyn C Turner
10 Mar 2022
21 CFR 820.30(d)
Design output - review and approval
Cited by Richard T Riggie, Jocelyn C Turner
10 Mar 2022
21 CFR 820.30(f)
Design verification - Lack of or inadequate procedures
Cited by Richard T Riggie, Jocelyn C Turner
10 Mar 2022
21 CFR 820.30(g)
Design validation - user needs and intended uses
Cited by Richard T Riggie, Jocelyn C Turner
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 820.184 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.250(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind SENO MEDICAL INSTRUMENTS, 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