FDA Inspection
PROVERUM Ltd.PROVERUM Ltd. – FDA Inspection, Oct 16, 2025
Record Details
This FDA Inspection record concerns PROVERUM Ltd., with an inspection on October 16, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · 80add4c0-f37b-48e2-b319-6497d948a7b5
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1287238
- FDA center
- Medical Devices & Rad Health
- Project area
- Product Evaluation: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(c)Design input - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation - user needs and intended uses
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