FDA Inspection
SPES MEDICA S.P.A.SPES MEDICA S.P.A. – FDA Inspection, Mar 6, 2025
Record Details
This FDA Inspection record concerns SPES MEDICA S.P.A., with an inspection on March 6, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · 8dacdaa7-e6ce-4820-a750-e9d69e136292
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1262811
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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