FDA Inspection 1318410 — EMS Physio Ltd.
The FDA completed an inspection of EMS Physio Ltd. on May 21, 2026 in Irvine. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 21, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Irvine (United Kingdom)
Citations
| ID | CFR | Description |
|---|---|---|
| 23248 | ISO 13485:2016 Clause 8.3.4 | Rework records not maintained |