FDA Inspection 1308308 — Boule Medical AB

Boule Medical AB — FEI 3004008703

The FDA completed an inspection of Boule Medical AB on February 19, 2026 in Spanga. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). Product area: Devices.

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
February 19, 2026
Fiscal Year
2026
Product Type
Devices
Project Area
Compliance: Devices
Location
Spanga (Sweden)