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DR. MYKO SAN-ZDRAVLJE IZ GLJIVA d.o.o.

⚠️ High Risk

FEI: 3009204575 • Zagreb-slobostina, Grad Zagreb • CROATIA

FEI

FEI Number

3009204575

📍

Location

Zagreb-slobostina, Grad Zagreb

🇭🇷

Country

CROATIA
🏢

Address

Production site: Sveta Nedjelja, Headquarters: Vijenac Frane Gotovca 8, Zagreb-slobostina, Grad Zagreb, Croatia

High Risk

FDA Import Risk Assessment

57.6
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
12/29/2023
Latest Refusal
12/29/2023
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
22.3×30%
Recency
59.4×20%
Frequency
30.0×10%
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

753×

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
12/29/2023
54FYR99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)
12/29/2023
54FYR99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)
12/29/2023
54FYR99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is DR. MYKO SAN-ZDRAVLJE IZ GLJIVA d.o.o.'s FDA import refusal history?

DR. MYKO SAN-ZDRAVLJE IZ GLJIVA d.o.o. (FEI: 3009204575) has 3 FDA import refusal record(s) in our database, spanning from 12/29/2023 to 12/29/2023.

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. DR. MYKO SAN-ZDRAVLJE IZ GLJIVA d.o.o.'s FEI number is 3009204575.

What types of violations has DR. MYKO SAN-ZDRAVLJE IZ GLJIVA d.o.o. received?

DR. MYKO SAN-ZDRAVLJE IZ GLJIVA d.o.o. 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 DR. MYKO SAN-ZDRAVLJE IZ GLJIVA d.o.o. come from?

All FDA import refusal data for DR. MYKO SAN-ZDRAVLJE IZ GLJIVA d.o.o. 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.