FDA Inspection
EMS Physio Ltd.EMS Physio Ltd. – FDA Inspection, May 21, 2026
Record Details
This FDA Inspection record concerns EMS Physio Ltd., with an inspection on May 21, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · b1373a09-711b-4e31-93e5-c40b8a89c0ae
Inspection Facts
- Inspection number
- 1318410
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- ISO 13485:2016 Clause 8.3.4Rework records not maintained
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Other FDA inspections of EMS Physio Ltd.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 13, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 2, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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