FDA Inspection 1280400 — Fogless International AB
The FDA completed an inspection of Fogless International AB on August 28, 2025 in Vaggeryd. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 28, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Vaggeryd (Sweden)
Citations
| ID | CFR | Description |
|---|---|---|
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |