FDA Inspection 1268019 — UNIREGEN Spol S.R.O.
The FDA completed an inspection of UNIREGEN Spol S.R.O. on Apr 25, 2025 in Nachod. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 4 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Apr 25, 2025
- Fiscal Year
- 2025
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Nachod (Czech Republic)
Citations
| ID | CFR | Description |
|---|---|---|
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 18154 | 21 CFR 117.80(a)(2) | Appropriate quality control operations |
| 22843 | 21 CFR 111.70(b) | Specifications - components |
| 4520 | 21 CFR 108.35(c)(3)(ii) | Process information availability |