Pharmamed Mado
✅ Low Risk
FEI: 3012284664 • Zagreb, Grad Zagreb • CROATIA
FEI Number
3012284664
Location
Zagreb, Grad Zagreb
Country
CROATIAAddress
Ulica Franje Lucica 23, , Zagreb, Grad Zagreb, Croatia
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/7/2016 | 80FRNPUMP, INFUSION | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Pharmamed Mado's FDA import refusal history?
Pharmamed Mado (FEI: 3012284664) has 1 FDA import refusal record(s) in our database, spanning from 6/7/2016 to 6/7/2016.
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. Pharmamed Mado's FEI number is 3012284664.
What types of violations has Pharmamed Mado received?
Pharmamed Mado 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 Pharmamed Mado come from?
All FDA import refusal data for Pharmamed Mado 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.