FDA Inspection 1101283 — Conservas Isabel Ecuatoriana S.A.
The FDA completed an inspection of Conservas Isabel Ecuatoriana S.A. on September 3, 2019 in Manta. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 3, 2019
- Fiscal Year
- 2019
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Manta (Ecuador)
Citations
| ID | CFR | Description |
|---|---|---|
| 18161 | 21 CFR 117.80(c) | Manufacturing, processing, packing, holding - Controls |
| 3874 | 21 CFR 113.60(b) | Cooling water - not chlorinated, sanitized |
| 3877 | 21 CFR 113.60(c) | Coding - required elements |
| 4179 | 21 CFR 113.83 | Records of process establishment |
| 6008 | 21 CFR 123.8(a)(3) | Verification - record review - frequency |
| 959 | 21 CFR 123.6(c)(1) | Food safety hazards |