FDA Inspection 1083275 — C.I. Dona Paula S.A.
The FDA completed an inspection of C.I. Dona Paula S.A. on March 20, 2019 in Itagui. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 20, 2019
- Fiscal Year
- 2019
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Itagui (Colombia)
Citations
| ID | CFR | Description |
|---|---|---|
| 1045 | 21 CFR 113.10 | Supervisors |
| 1300 | 21 CFR 113.81(c) | Fill |
| 1642 | 21 CFR 113.100(b) | Review not signed/dated |
| 2169 | 21 CFR 113.40(b)(10) | Operator check, record, frequency |
| 4179 | 21 CFR 113.83 | Records of process establishment |