Fresh Directions Dominicana S.A. — FDA Facility Profile
Fresh Directions Dominicana S.A. is an FDA-inspected facility (FEI 3004146490) located in San Cristobal. RegDataLab tracks 4 FDA inspections and 1 compliance action at this facility.
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What FDA found at this site
- Latest inspection
- May 30, 2023: No Action Indicated (NAI)
- Inspections on record
- 4 (2 OAI, 1 VAI, 1 NAI)
- Last OAI inspection
- May 21, 2015
- Warning letters
- 1 listed by FDA for this FEI, latest Nov 25, 2013
- Import refusals
- 4
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| May 30, 2023 | No Action Indicated (NAI) | No citations listed |
| Nov 21, 2016 | Voluntary Action Indicated (VAI) | Records required - not maintained (21 CFR 120.12(a)) HACCP plan not implemented (21 CFR 120.8(a)) HACCP plan - critical control points not listed (21 CFR 120.8(b)(2)) Manufacturing conditions (21 CFR 110.80(b)(2)) and 1 more |
| May 21, 2015 | Official Action Indicated (OAI) | HACCP plan not implemented (21 CFR 120.8(a)) HACCP plan - monitoring procedures not adequate (21 CFR 120.8(b)(4)) HACCP plan - food hazards not listed (21 CFR 120.8(b)(1)) HACCP plan - critical limits not listed or not adequate (21 CFR 120.8(b)(3)) and 3 more |
| Jun 21, 2013 | Official Action Indicated (OAI) | No citations listed |
Facility details
- Company
- Fresh Directions Dominicana S.A.
- Location
- San Cristobal
- Source
- inspections