Fresh Directions Dominicana S.A.
⚠️ Moderate Risk
FEI: 3004146490 • San Cristobal, San Cristobal • DOMINICAN REPUBLIC
FEI Number
3004146490
Location
San Cristobal, San Cristobal
Country
DOMINICAN REPUBLICAddress
Calle Segunda #5, El Mango, Quita Sueno, , San Cristobal, San Cristobal, Dominican Republic
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
PESTICIDE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a pesticide chemical residue, which causes the article to be adulterated within the meaning of section 402(a)(2)(B) of the FD&C Act. Bears or contains:
LISTERIA
The article is subject to refusal of admission pursuant to Section 801(a)(3), in that the article appears to contain Listeria monocytogenes, a poisonous and deleterious substance, which may render it injurious to health.
JUICEHACCP
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed, or held under insanitary conditions, or it may be injurious to health, due to failure of the foreign processor to comply with 21 CFR 120.
RX DEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/14/2015 | 21XGD05MANGO (SUBTROPICAL/TROPICAL FRUIT PULP) | 3621JUICEHACCP | Florida District Office (FLA-DO) |
| 1/11/2012 | 24FFC07PEPPER, SWEET (FRUIT USED AS VEGETABLE) | 241PESTICIDE | Florida District Office (FLA-DO) |
| 4/14/2009 | 21IGT02AVOCADO (PIT FRUIT PUREES) | 295LISTERIA | Los Angeles District Office (LOS-DO) |
| 10/17/2003 | 86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY | 84RX DEVICE | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Fresh Directions Dominicana S.A.'s FDA import refusal history?
Fresh Directions Dominicana S.A. (FEI: 3004146490) has 4 FDA import refusal record(s) in our database, spanning from 10/17/2003 to 4/14/2015.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Fresh Directions Dominicana S.A.'s FEI number is 3004146490.
What types of violations has Fresh Directions Dominicana S.A. received?
Fresh Directions Dominicana S.A. has been cited for 4 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Fresh Directions Dominicana S.A. come from?
All FDA import refusal data for Fresh Directions Dominicana S.A. is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.