FDA Inspection
EMS Physio Ltd.EMS Physio Ltd. – FDA Inspection, Dec 13, 2023
Record Details
This FDA Inspection record concerns EMS Physio Ltd., with an inspection on December 13, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 38a31531-7317-4880-b50d-c8fa9903bc9f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1224830
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
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Other FDA inspections of EMS Physio Ltd.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 21, 2026 | Not classified | Office of Inspections and Investigations | Postmarket Assurance: Devices |
| September 2, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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