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Belupo Pharmaceuticals And Cosmetic Inc

⚠️ High Risk

FEI: 3012044206 • Koprivnica, Koprivnicko-Krizevacka • CROATIA

FEI

FEI Number

3012044206

📍

Location

Koprivnica, Koprivnicko-Krizevacka

🇭🇷

Country

CROATIA
🏢

Address

Ulica Danica 5, , Koprivnica, Koprivnicko-Krizevacka, Croatia

High Risk

FDA Import Risk Assessment

55.9
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

2
Total Refusals
1
Unique Violations
5/16/2025
Latest Refusal
2/29/2016
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
17.7×30%
Recency
71.9×20%
Frequency
2.2×10%
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

752×

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

DateProductViolationsDivision
5/16/2025
64LDJ03BETAMETHASONE (GLUCOCORTICOID)
75UNAPPROVED
Division of Southeast Imports (DSEI)
2/29/2016
64LDY03BETAMETHASONE (GLUCOCORTICOID)
75UNAPPROVED
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is Belupo Pharmaceuticals And Cosmetic Inc's FDA import refusal history?

Belupo Pharmaceuticals And Cosmetic Inc (FEI: 3012044206) has 2 FDA import refusal record(s) in our database, spanning from 2/29/2016 to 5/16/2025.

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. Belupo Pharmaceuticals And Cosmetic Inc's FEI number is 3012044206.

What types of violations has Belupo Pharmaceuticals And Cosmetic Inc received?

Belupo Pharmaceuticals And Cosmetic Inc 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 Belupo Pharmaceuticals And Cosmetic Inc come from?

All FDA import refusal data for Belupo Pharmaceuticals And Cosmetic Inc 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.