FDA Inspection 1312944 — Zaklady Przemyslu Cukierniczego Otmuchow S.A.
The FDA completed an inspection of Zaklady Przemyslu Cukierniczego Otmuchow S.A. on April 17, 2026 in Nysa. 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
- April 17, 2026
- Fiscal Year
- 2026
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Nysa (Poland)
Citations
| ID | CFR | Description |
|---|---|---|
| 18161 | 21 CFR 117.80(c) | Manufacturing, processing, packing, holding - Controls |
| 22714 | 21 CFR 117.410(c) | Supply-chain program - Assurance (Adequate) |
| 22717 | 21 CFR 117.130(a)(1) | Hazard analysis - Identification of hazard |