FDA Inspection 1110235 — SoliPharma B.V.
The FDA completed an inspection of SoliPharma B.V. on Nov 15, 2019 in Oudenbosch. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 5 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection details
- Classification
- No Action Indicated (NAI)
- End Date
- Nov 15, 2019
- Fiscal Year
- 2020
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Oudenbosch (Netherlands)
Citations
| ID | CFR | Description |
|---|---|---|
| 15395 | 21 CFR 111.10(b)(5) | Gloves |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 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 |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |