FDA Inspection 980744 — Sabila, SRL
The FDA completed an inspection of Sabila, SRL on June 15, 2016 in Villa Gonzalez. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 15, 2016
- Fiscal Year
- 2016
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Villa Gonzalez (Dominican Republic (the))
Citations
| ID | CFR | Description |
|---|---|---|
| 1007 | 21 CFR 110.10(b)(9) | Precautions against contamination--micro, foreign substances |
| 1173 | 21 CFR 110.40(f) | Q.C. instrument accuracy, maintenance |
| 1306 | 21 CFR 110.20(b)(7) | Screening |
| 1406 | 21 CFR 110.10(b)(6) | Effective use of hair restraint |
| 3071 | 21 CFR 114.80(a)(1) | Scheduled process |
| 3080 | 21 CFR 114.83 | Scheduled process establishment |
| 3082 | 21 CFR 114.89 | Process deviation |