FDA Inspection 1064621 — Scelta Essenza BV
The FDA completed an inspection of Scelta Essenza BV on Aug 28, 2018 in Venlo. 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
- Aug 28, 2018
- Fiscal Year
- 2018
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Venlo (Netherlands)
Citations
| ID | CFR | Description |
|---|---|---|
| 1040 | 21 CFR 113.10 | Operators |
| 1642 | 21 CFR 113.100(b) | Review not signed/dated |
| 2149 | 21 CFR 113.40(b)(1)(v) | TID not reference instrument |
| 2151 | 21 CFR 113.40(b)(2)(i) | Range, chart graduations |
| 2206 | 21 CFR 113.40(b)(15) | Measured, recorded |
| 3874 | 21 CFR 113.60(b) | Cooling water - not chlorinated, sanitized |
| 3877 | 21 CFR 113.60(c) | Coding - required elements |