FDA Inspection 618388 — Caribex Dominicana S.A.
The FDA completed an inspection of Caribex Dominicana S.A. on August 21, 2009 in San Cristobal. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 12 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 21, 2009
- Fiscal Year
- 2009
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- San Cristobal (Dominican Republic (the))
Citations
| ID | CFR | Description |
|---|---|---|
| 1287 | 21 CFR 110.20(a)(1) | Harborage areas |
| 1471 | 21 CFR 113.83 | Scheduled processes not established |
| 1487 | 21 CFR 113.87(b) | Visual indicators not used |
| 1553 | 21 CFR 110.35(a) | Buildings/good repair |
| 1560 | 21 CFR 110.35(c) | Lack of effective pest exclusion |
| 1649 | 21 CFR 113.40(a)(1)(iv) | MIG - range |
| 1651 | 21 CFR 113.40(a)(1) | TID accuracy test frequency |
| 1660 | 21 CFR 113.40(a)(1)(v) | TID not reference instrument |
| 1756 | 21 CFR 113.40(a)(8) | Condensate bleeder - bottom vented retort |
| 3864 | 21 CFR 113.60(a)(1) | Recording of teardown examinations |
| 4515 | 21 CFR 108.35(c)(2) | Process filing |
| 4523 | 21 CFR 108.35(f) | Recall procedures |