Overview
- 4 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-03-05.
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 |
|---|---|---|---|
| 2 Mar 2026 – 5 Mar 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 28 Mar 2016 – 31 Mar 2016 | Medical Devices & Rad Health | Clean | |
| 27 May 2013 – 30 May 2013 | Medical Devices & Rad Health | Clean | |
| 4 Mar 2010 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
5 Mar 2026
ISO 13485:2016 Clause 4.1.2
Risk-based approach not applied to QMS processes
Cited by Jude C Dike
5 Mar 2026
ISO 13485:2016 Clause 7.3.8
Design and development transfer procedures not documented
Cited by Jude C Dike
5 Mar 2026
ISO 13485:2016 Clause 7.5.6
Process for production and service provision not validated
Cited by Jude C Dike
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 807.40(a) | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 4.1.2 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.3.8 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.5.6 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind SunMed AP, Ltd.'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