Company
IrelandENTERASENSE LIMITED, Galway, Ireland – FDA Inspections
Inspection records and compliance data for ENTERASENSE LIMITED in Galway. 1 FDA inspection on record, 1 Form 483, last inspected August 07, 2026.
Company Profile
This profile covers ENTERASENSE LIMITED based in Galway, Ireland.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 0
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
Inspected August 7, 2026.
Most cited issue areas
- Corrective action procedures not documented1 inspection
- Design and development verification not performed1 inspection
- Monitoring and measurement requirements of product characteristics are not met1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 7, 2026 | Not classified | Medical Devices & Rad Health · Compliance: Devices | 1330794 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
ENTERASENSE LIMITED
FEI Number
3027502350
Address
Block 4 Ballybrit Business Park, Galway, Ireland
Country
Ireland
ID: 158fc23b-92a9-4cb3-bc5a-2805d547769d