FDA Inspection 618428 — Ilguiflod S.A.
The FDA completed an inspection of Ilguiflod S.A. on August 25, 2009 in Santo Domingo. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 20 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 25, 2009
- Fiscal Year
- 2009
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Santo Domingo (Dominican Republic (the))
Citations
| ID | CFR | Description |
|---|---|---|
| 1287 | 21 CFR 110.20(a)(1) | Harborage areas |
| 1306 | 21 CFR 110.20(b)(7) | Screening |
| 1427 | 21 CFR 110.20(b)(5) | Safety lighting and glass |
| 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 |
| 1597 | 21 CFR 110.37(b)(3) | As source of contamination |
| 1649 | 21 CFR 113.40(a)(1)(iv) | MIG - range |
| 1651 | 21 CFR 113.40(a)(1) | TID accuracy test frequency |
| 1653 | 21 CFR 113.40(a)(1)(v) | TID not accurately, easily read |
| 1731 | 21 CFR 113.40(a)(2) | Present each retort, accurate |
| 1756 | 21 CFR 113.40(a)(8) | Condensate bleeder - bottom vented retort |
| 2388 | 21 CFR 110.80(a)(5) | Holding in bulk or suitable containers |
| 3652 | 21 CFR 110.37(e)(1) | Suitable locations |
| 3771 | 21 CFR 113.40(a)(7) | Location of steam spreader perforations (S) |
| 3775 | 21 CFR 113.40(a)(9) | Perforations size-sheet metal bottoms, dividers (S) |
| 4514 | 21 CFR 108.35(c)(1) | Registration |
| 4523 | 21 CFR 108.35(f) | Recall procedures |
| 4524 | 21 CFR 108.35(g) | Approved school |
| 4529 | 21 CFR 108.35(c)(2)(ii) | Process change reporting to CFSAN |