FDA Inspection 1294582 — Faun Pharma AS
The FDA completed an inspection of Faun Pharma AS on November 28, 2025 in Vestby. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 28, 2025
- Fiscal Year
- 2026
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Vestby (Norway)
Citations
| ID | CFR | Description |
|---|---|---|
| 15870 | 21 CFR 111.75(c)(1) | Specifications met - verify; production, process control |
| 22843 | 21 CFR 111.70(b) | Specifications - components |
| 22888 | 21 CFR 111.210 | Master manufacturing record - record requirements |
| 22890 | 21 CFR 111.260 | Batch record - required information |