FEI 3004530184
Andersen Caledonia Ltd
Caledonian House, Phoenix Crescent, Bellshill Scotland, GB
MDR events0All time
Recalls0All time
Registered products72
Establishment typeSterilizeSterilize Medical Device for Another Party (Contract Sterilizer)
Registered product codes
72 product codes
Recent MDR events
0 on file
No MDR events on file for this firm name.
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 3004530184.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Sep 18, 2025
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Sep 18, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
4 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.20(c)Sep 18, 2025
Management review - Lack of or inadequate procedures
- 21 CFR 820.70(a)Sep 18, 2025
Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.70(e)Sep 18, 2025
Contamination control, Lack of or inadequate procedures
- 21 CFR 820.75(a)Sep 18, 2025
Lack of or inadequate process validation
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
1 on file
Top refusal reasons
Compare to industry ↗- Division of Southeast Imports (DSEI)Jul 13, 2026
75QCD \ CONTINUOUS GLUCOSE MONITOR, IMPLANTED, ADJUNCTIVE USE