Laboratorio Elea Sa S.A.C.I Fya
⚠️ Moderate Risk
FEI: 3005129585 • Buenos Aires • ARGENTINA
FEI Number
3005129585
Location
Buenos Aires
Country
ARGENTINAAddress
Sanabria 2353 (C 1417 Aze), , Buenos Aires, , 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
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 Laboratorio Elea Sa S.A.C.I Fya's FDA import refusal history?
Laboratorio Elea Sa S.A.C.I Fya (FEI: 3005129585) has 2 FDA import refusal record(s) in our database, spanning from 10/21/2006 to 6/22/2009.
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. Laboratorio Elea Sa S.A.C.I Fya's FEI number is 3005129585.
What types of violations has Laboratorio Elea Sa S.A.C.I Fya received?
Laboratorio Elea Sa S.A.C.I Fya has been cited for 1 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 Laboratorio Elea Sa S.A.C.I Fya come from?
All FDA import refusal data for Laboratorio Elea Sa S.A.C.I Fya 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.