FDA Inspection 1102053 — TIERRA LINDA
The FDA completed an inspection of TIERRA LINDA on Sep 6, 2019 in Ambato. 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). 7 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 6, 2019
- Fiscal Year
- 2019
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Ambato (Ecuador)
Citations
| ID | CFR | Description |
|---|---|---|
| 18161 | 21 CFR 117.80(c) | Manufacturing, processing, packing, holding - Controls |
| 3086 | 21 CFR 114.100(b) | Maintenance of processing and production records |
| 4179 | 21 CFR 113.83 | Records of process establishment |
| 4511 | 21 CFR 108.25(f) | Approved school |
| 4519 | 21 CFR 108.35(c)(3)(i) | Process adherence |
| 9935 | 21 CFR 120.7(a) | No hazard analysis |
| 9981 | 21 CFR 120.12(b)(4) | Records - actual values |