Sheffield Precision Medical Ltd
Unit 1 Wylcut-House, Sheffield, GB
Registered product codes
22 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 3009871135.
FDA inspections
1 on file
- Official Action Indicated (OAI)Oct 23, 2025
Compliance: Devices · Citations posted
Inspection citations
6 on file
Top cited requirements
Compare to industry ↗21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
121 CFR 820.70(g)(3)Adjustment
121 CFR 820.75(a)Lack of or inadequate process validation
121 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
121 CFR 820.100(a)Lack of or inadequate procedures
121 CFR 820.184DHR content
1
- 21 CFR 820.70(g)(1)Oct 23, 2025
Maintenance schedule, Lack of or inadequate schedule
- 21 CFR 820.70(g)(3)Oct 23, 2025
Adjustment
- 21 CFR 820.75(a)Oct 23, 2025
Lack of or inadequate process validation
- 21 CFR 820.80(c)Oct 23, 2025
Lack of or inadequate In-process acceptance procedures
- 21 CFR 820.100(a)Oct 23, 2025
Lack of or inadequate procedures
- 21 CFR 820.184Oct 23, 2025
DHR content
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.