FDA Inspection 1294074 — EPISURF OPERATIONS AB
The FDA completed an inspection of EPISURF OPERATIONS AB on November 11, 2025 in Stockholm. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 11, 2025
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Stockholm (Sweden)