Company
United KingdomEMS Physio Ltd., Irvine, United Kingdom – FDA Inspections
Inspection records and compliance data for EMS Physio Ltd. in Irvine. 3 FDA inspections on record, 2 Form 483s, last inspected May 21, 2026.
Company Profile
This profile covers EMS Physio Ltd. based in Irvine, United Kingdom.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected September 2, 2016. Last inspected May 21, 2026.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design control - no procedures1 inspection
- Documentation1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 21, 2026 | Not classified | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1318410 |
| December 13, 2023 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1224830 |
| September 2, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 988262 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
EMS Physio Ltd.
FEI Number
3004154499
Address
Annickbank Campus, Greig House, Block 1; Annick Road, Irvine, United Kingdom
Country
United Kingdom
ID: 66a7640d-04a9-4c73-a2c2-c6ceb6d44333