FDA Inspection 1203452 — Gondi S.A.
The FDA completed an inspection of Gondi S.A. on April 24, 2023 in Portoviejo. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 10 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 24, 2023
- Fiscal Year
- 2023
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Portoviejo (Ecuador)
Citations
| ID | CFR | Description |
|---|---|---|
| 1040 | 21 CFR 113.10 | Operators |
| 1524 | 21 CFR 123.11(b) | Sanitation monitoring |
| 16307 | 21 CFR 113.40(a)(8) | Still steam retorts: Bleeder not wide open during process |
| 1734 | 21 CFR 113.40(a)(2)(iii) | Adjusted to agree with TID |
| 2101 | 21 CFR 113.40(a)(13) | Measured, recorded |
| 3878 | 21 CFR 113.60(c) | Coding - Change of pack period |
| 3879 | 21 CFR 113.60(d) | Postprocess handling: checks, repairs |
| 4179 | 21 CFR 113.83 | Records of process establishment |
| 4181 | 21 CFR 113.89 | Process deviation identification |
| 4519 | 21 CFR 108.35(c)(3)(i) | Process adherence |