Ecorganicos de Colombia SAS
⚠️ Moderate Risk
FEI: 3010642070 • Bogota, Cundinamarca • COLOMBIA
FEI Number
3010642070
Location
Bogota, Cundinamarca
Country
COLOMBIAAddress
Calle 119 14b 14-25 Oficina 202, , Bogota, Cundinamarca, Colombia
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).
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.
Refusal History
Frequently Asked Questions
What is Ecorganicos de Colombia SAS's FDA import refusal history?
Ecorganicos de Colombia SAS (FEI: 3010642070) has 1 FDA import refusal record(s) in our database, spanning from 1/31/2014 to 1/31/2014.
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. Ecorganicos de Colombia SAS's FEI number is 3010642070.
What types of violations has Ecorganicos de Colombia SAS received?
Ecorganicos de Colombia SAS 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 Ecorganicos de Colombia SAS come from?
All FDA import refusal data for Ecorganicos de Colombia SAS 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.