Atractiva Dominicana
✅ Low Risk
FEI: 3007817119 • Santo Domingo • DOMINICAN REPUBLIC
FEI Number
3007817119
Location
Santo Domingo
Country
DOMINICAN REPUBLICAddress
Calle Palma Rosa #8, Sector Palmarito, , Santo Domingo, , Dominican Republic
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
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
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
Frequently Asked Questions
What is Atractiva Dominicana's FDA import refusal history?
Atractiva Dominicana (FEI: 3007817119) has 1 FDA import refusal record(s) in our database, spanning from 8/1/2012 to 8/1/2012.
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. Atractiva Dominicana's FEI number is 3007817119.
What types of violations has Atractiva Dominicana received?
Atractiva Dominicana has been cited for 3 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 Atractiva Dominicana come from?
All FDA import refusal data for Atractiva Dominicana 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.