Mbe Ojeda Ca
⚠️ Moderate Risk
FEI: 3003539833 • Ciudad • VENEZUELA
FEI Number
3003539833
Location
Ciudad
Country
VENEZUELAAddress
Morachas Edf 308, , Ciudad, , Venezuela
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
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 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
Frequently Asked Questions
What is Mbe Ojeda Ca's FDA import refusal history?
Mbe Ojeda Ca (FEI: 3003539833) has 1 FDA import refusal record(s) in our database, spanning from 12/21/2006 to 12/21/2006.
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. Mbe Ojeda Ca's FEI number is 3003539833.
What types of violations has Mbe Ojeda Ca received?
Mbe Ojeda Ca 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 Mbe Ojeda Ca come from?
All FDA import refusal data for Mbe Ojeda Ca 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.