Electromedicina De Marcelo G Andrad
⚠️ Moderate Risk
FEI: 3005796269 • Ciudad Autonoma Buenos Aires, Buenos Aires • ARGENTINA
FEI Number
3005796269
Location
Ciudad Autonoma Buenos Aires, Buenos Aires
Country
ARGENTINAAddress
Calle Fonrouge 1839, , Ciudad Autonoma Buenos Aires, 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
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).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
Refusal History
Frequently Asked Questions
What is Electromedicina De Marcelo G Andrad's FDA import refusal history?
Electromedicina De Marcelo G Andrad (FEI: 3005796269) has 2 FDA import refusal record(s) in our database, spanning from 8/22/2006 to 8/22/2006.
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. Electromedicina De Marcelo G Andrad's FEI number is 3005796269.
What types of violations has Electromedicina De Marcelo G Andrad received?
Electromedicina De Marcelo G Andrad has been cited for 3 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 Electromedicina De Marcelo G Andrad come from?
All FDA import refusal data for Electromedicina De Marcelo G Andrad 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.