EC LABS SA
⚠️ Moderate Risk
FEI: 3027086256 • Cordoba, Cordoba • ARGENTINA
FEI Number
3027086256
Location
Cordoba, Cordoba
Country
ARGENTINAAddress
Barrio Los Boulevares, Pasaje Tucuman 250, Cordoba, Cordoba, Argentina
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
708NEWANIM
The article has been determined to be a new animal drug without an approved new animal drug application.
708LISTING
It has been determined the drug is not included in a list required by Section 510(j).
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Refusal History
Frequently Asked Questions
What is EC LABS SA's FDA import refusal history?
EC LABS SA (FEI: 3027086256) has 2 FDA import refusal record(s) in our database, spanning from 5/19/2023 to 5/19/2023.
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. EC LABS SA's FEI number is 3027086256.
What types of violations has EC LABS SA received?
EC LABS SA 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 EC LABS SA come from?
All FDA import refusal data for EC LABS SA 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.