FDA Inspection 1307202 — NALUEC S.A.S.
The FDA completed an inspection of NALUEC S.A.S. on Mar 12, 2026 in Santiago De Pillaro. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 9 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 12, 2026
- Fiscal Year
- 2026
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Santiago De Pillaro (Ecuador)
Citations
| ID | CFR | Description |
|---|---|---|
| 12742 | 21 CFR 120.8(a) | HACCP plan not implemented |
| 12743 | 21 CFR 120.8(b)(4) | HACCP plan - monitoring procedures not adequate |
| 12747 | 21 CFR 120.8(b)(3) | HACCP plan - critical limits not listed or not adequate |
| 12748 | 21 CFR 120.8(b)(5) | HACCP plan - corrective action plan not included |
| 12749 | 21 CFR 120.8(b)(6) | HACCP plan - verify procedures / frequency - none listed |
| 12750 | 21 CFR 120.8(b)(6) | HACCP plan - valid procedures / frequency - none listed |
| 18146 | 21 CFR 117.35(d) | Sanitation of food-contact surfaces - Frequency |
| 18149 | 21 CFR 117.40 | Equipment and utensils - Design and maintenance |
| 9986 | 21 CFR 120.24(c) | Process controls - not exempt, single facility |