FDA Warning Letter — Boule Medical AB
The FDA took a Warning Letter action against Boule Medical AB on October 2, 2018 (Spanga, Sweden). The action was issued by CDRH and concerns devices products. This facility has 3 recent FDA inspections on record.
Action Details
- Facility
- Boule Medical AB
- Date
- October 2, 2018
- Fiscal Year
- 2019
- Product Type
- Devices
- Center
- CDRH
- Location
- Spanga (Sweden)