FDA Inspection 918147 — Agrol S.A.
The FDA completed an inspection of Agrol S.A. on March 16, 2015 in Manta. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 16, 2015
- Fiscal Year
- 2015
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Manta (Ecuador)
Citations
| ID | CFR | Description |
|---|---|---|
| 1524 | 21 CFR 123.11(b) | Sanitation monitoring |
| 1525 | 21 CFR 123.11(c) | Sanitation Records |
| 6005 | 21 CFR 123.6(c)(6) | Verification procedures - adequacy |
| 905 | 21 CFR 123.6(b) | HACCP plan implementation |
| 959 | 21 CFR 123.6(c)(1) | Food safety hazards |
| 960 | 21 CFR 123.6(c)(2) | Critical control points |
| 961 | 21 CFR 123.6(c)(3) | Critical limits |