FDA Inspection 1230122 — Oleon Americas
The FDA completed an inspection of Oleon Americas on February 16, 2024 in Simpsonville, SC. 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: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 16, 2024
- Fiscal Year
- 2024
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Simpsonville, SC (United States)
Additional Details
FSVP
Citations
| ID | CFR | Description |
|---|---|---|
| 18262 | 21 CFR 1.504(a) | Hazard analysis written |
| 18281 | 21 CFR 1.505(a)(2) | Evaluation - performance, risk |
| 18303 | 21 CFR 1.506(e)(1) | Verification activity before import, periodically |