FDA Inspection 1271323 — Gueldenkron Fruchtsaft GmbH
The FDA completed an inspection of Gueldenkron Fruchtsaft GmbH on May 28, 2025 in Nistertal. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 28, 2025
- Fiscal Year
- 2025
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Nistertal (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 1040 | 21 CFR 113.10 | Operators |
| 1471 | 21 CFR 113.83 | Scheduled processes not established |
| 2826 | 21 CFR 113.40(g)(1)(ii)(A) | Startup - commercial sterility |
| 2838 | 21 CFR 113.40(g)(1)(i)(A) | No accurate TID |
| 2846 | 21 CFR 113.40(g)(1)(i)(B)(1) | Recorder range, chart graduations |
| 2862 | 21 CFR 113.40(g)(1)(i)(G) | Holding tube - heated, slope |
| 4519 | 21 CFR 108.35(c)(3)(i) | Process adherence |
| 4520 | 21 CFR 108.35(c)(3)(ii) | Process information availability |