FDA Inspection 1053546 — Boule Medical AB
The FDA completed an inspection of Boule Medical AB on May 11, 2018 in Spanga. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 11, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Spanga (Sweden)