Distribuidora Yenni Mercado Orientalmanagua C
✅ Low Risk
FEI: 3008114124 • Managuanicaragua • NICARAGUA
FEI Number
3008114124
Location
Managuanicaragua
Country
NICARAGUAAddress
A Una Cuadra Al Surmedia Cuadra, , Managuanicaragua, , Nicaragua
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).
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 Distribuidora Yenni Mercado Orientalmanagua C's FDA import refusal history?
Distribuidora Yenni Mercado Orientalmanagua C (FEI: 3008114124) has 1 FDA import refusal record(s) in our database, spanning from 3/12/2010 to 3/12/2010.
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. Distribuidora Yenni Mercado Orientalmanagua C's FEI number is 3008114124.
What types of violations has Distribuidora Yenni Mercado Orientalmanagua C received?
Distribuidora Yenni Mercado Orientalmanagua C has been cited for 2 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 Distribuidora Yenni Mercado Orientalmanagua C come from?
All FDA import refusal data for Distribuidora Yenni Mercado Orientalmanagua C 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.