FDA Inspection
SAPI MED S.p.a.SAPI MED S.p.a. – FDA Inspection, Feb 20, 2025
Record Details
This FDA Inspection record concerns SAPI MED S.p.a., with an inspection on February 20, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · 6b0b90fb-132a-4386-85e2-9f89abc5cc66
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1261643
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.184DHR content
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