FDA Inspection 1276924 — Productos Schullo S.A.
The FDA completed an inspection of Productos Schullo S.A. on July 25, 2025 in Quito. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 25, 2025
- Fiscal Year
- 2025
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Quito (Ecuador)
Citations
| ID | CFR | Description |
|---|---|---|
| 22717 | 21 CFR 117.130(a)(1) | Hazard analysis - Identification of hazard |
| 22718 | 21 CFR 117.135(c)(1) | Process preventive controls - Appropriate (Adequate) |