FDA Inspection 997266 — Fresh Directions Dominicana S.A.
The FDA completed an inspection of Fresh Directions Dominicana S.A. on Nov 21, 2016 in San Cristobal. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 21, 2016
- Fiscal Year
- 2017
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- San Cristobal (Dominican Republic (the))
Citations
| ID | CFR | Description |
|---|---|---|
| 12734 | 21 CFR 120.12(a) | Records required - not maintained |
| 12742 | 21 CFR 120.8(a) | HACCP plan not implemented |
| 12746 | 21 CFR 120.8(b)(2) | HACCP plan - critical control points not listed |
| 1695 | 21 CFR 110.80(b)(2) | Manufacturing conditions |
| 9928 | 21 CFR 120.12(b) | Records - general - include name, date, time |