FDA Inspection 1276306 — Sophysa

Sophysa — FEI 3001587388

The FDA completed an inspection of Sophysa on June 12, 2025 in Besancon. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 1 citation was issued during this inspection. Product area: Devices.

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
June 12, 2025
Fiscal Year
2025
Product Type
Devices
Project Area
Compliance: Devices
Location
Besancon (France)

Citations

IDCFRDescription
73121 CFR 803.50(a)(1)Report of Death or Serious Injury