FDA Inspection 1274506 — Valens Int. D.O.O.
The FDA completed an inspection of Valens Int. D.O.O. on Jun 27, 2025 in Komenda. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 7 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 27, 2025
- Fiscal Year
- 2025
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Komenda (Slovenia)
Citations
| ID | CFR | Description |
|---|---|---|
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 22836 | 21 CFR 111.27(a) | Equipment - design - appropriate and suitable |
| 22843 | 21 CFR 111.70(b) | Specifications - components |
| 22847 | 21 CFR 111.70(e) | Specifications - finished dietary supplement |
| 22890 | 21 CFR 111.260 | Batch record - required information |
| 22908 | 21 CFR 111.503 | Written procedures - establish; returned dietary supplements |