Overview
- 1 FDA inspection is on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2026-05-28.
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 |
|---|---|---|---|
| 26 May 2026 – 28 May 2026 | Medical Devices & Rad Health | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
28 May 2026
ISO 13485:2016 Clause 7.3.10
Design and development files not maintained
Cited by Brian R Hendricks
28 May 2026
ISO 13485:2016 Clause 7.3.10
Design and development files not maintained
Cited by Brian R Hendricks
28 May 2026
ISO 13485:2016 Clause 7.5.8
No documented system to assign unique device identification (UDI)
Cited by Brian R Hendricks
28 May 2026
ISO 13485:2016 Clause 7.5.8
No documented system to assign unique device identification (UDI)
Cited by Brian R Hendricks
Investigators
FDA investigators tied to this site in the record.
Brian R Hendricks1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| ISO 13485:2016 Clause 7.3.10 | Cited across public-safe Form 483 observations | 2x |
| ISO 13485:2016 Clause 7.5.8 | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind Apnomed, Inc.'s 1 Form 483
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