FDA Inspection 927167 — Fresh Directions Dominicana S.A.
The FDA completed an inspection of Fresh Directions Dominicana S.A. on May 21, 2015 in San Cristobal. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 21, 2015
- Fiscal Year
- 2015
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- San Cristobal (Dominican Republic (the))
Citations
| ID | CFR | Description |
|---|---|---|
| 12742 | 21 CFR 120.8(a) | HACCP plan not implemented |
| 12743 | 21 CFR 120.8(b)(4) | HACCP plan - monitoring procedures not adequate |
| 12745 | 21 CFR 120.8(b)(1) | HACCP plan - food hazards not listed |
| 12747 | 21 CFR 120.8(b)(3) | HACCP plan - critical limits not listed or not adequate |
| 12749 | 21 CFR 120.8(b)(6) | HACCP plan - verify procedures / frequency - none listed |
| 9930 | 21 CFR 120.6(c) | SSOP records |
| 9931 | 21 CFR 120.6(b) | Sanitation monitoring |