Ariel Michalewicz
✅ Low Risk
FEI: 3004859508 • Ciudad Autonoma Buenos Aires, Buenos Aires • ARGENTINA
FEI Number
3004859508
Location
Ciudad Autonoma Buenos Aires, Buenos Aires
Country
ARGENTINAAddress
Calle Virrey Del Pino 2416, , Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
Refusal History
Frequently Asked Questions
What is Ariel Michalewicz's FDA import refusal history?
Ariel Michalewicz (FEI: 3004859508) has 1 FDA import refusal record(s) in our database, spanning from 12/8/2014 to 12/8/2014.
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. Ariel Michalewicz's FEI number is 3004859508.
What types of violations has Ariel Michalewicz received?
Ariel Michalewicz 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 Ariel Michalewicz come from?
All FDA import refusal data for Ariel Michalewicz 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.