FDA Inspection
Sheffield Precision Medical LimitedFDA Inspection 1288264 - Sheffield Precision Medical Limited - October 23, 2025
Record Details
This FDA Inspection record concerns Sheffield Precision Medical Limited, with an inspection on October 23, 2025, covering devices.
- Inspection Date
- October 23, 2025
- Product Type
- Devices
- Person
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ID · 69d62791-ab2d-4933-9d37-2ae8bc8c1b0e
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1288264
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184DHR content
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
- 21 CFR 820.70(g)(3)Adjustment
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
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