Overview
- 3 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-05-21.
At a glance
Inspections
3
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 18 May 2026 – 21 May 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 11 Dec 2023 – 13 Dec 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 30 Aug 2016 – 2 Sep 2016 | Medical Devices & Rad Health | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
13 Dec 2023
21 CFR 820.30(i)
Design changes - Lack of or Inadequate Procedures
Cited by Shannon A Gregory
13 Dec 2023
21 CFR 820.70(a)
Process control procedures, Lack of or inadequate procedures
Cited by Shannon A Gregory
Investigators
FDA investigators tied to this site in the record.
Shannon A Gregory2 insp.
Lauren E Priest1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.200(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.3.4 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind EMS Physio Ltd.'s 3 Form 483s
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