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, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- October 23, 2025
- Product Type
- Medical Devices & Rad Health
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ID · fb1f6ed9-8292-4257-b107-592104bb1f37
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: Medical 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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