ImportRefusal LogoImportRefusal

IOULIA AND IRENE TSETI PHARMACEU

⚠️ High Risk

FEI: 3029996013 • Kifissia, Attica • GREECE

FEI

FEI Number

3029996013

📍

Location

Kifissia, Attica

🇬🇷

Country

GREECE
🏢

Address

Kaliftaki 27, , Kifissia, Attica, Greece

High Risk

FDA Import Risk Assessment

52.2
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
1/9/2024
Latest Refusal
1/9/2024
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
59.4×20%
Frequency
10.0×10%
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

751×

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
1/9/2024
66JDY01LEVOTHYROXINE SODIUM (THYROID HORMONE)
75UNAPPROVED
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is IOULIA AND IRENE TSETI PHARMACEU's FDA import refusal history?

IOULIA AND IRENE TSETI PHARMACEU (FEI: 3029996013) has 1 FDA import refusal record(s) in our database, spanning from 1/9/2024 to 1/9/2024.

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. IOULIA AND IRENE TSETI PHARMACEU's FEI number is 3029996013.

What types of violations has IOULIA AND IRENE TSETI PHARMACEU received?

IOULIA AND IRENE TSETI PHARMACEU 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 IOULIA AND IRENE TSETI PHARMACEU come from?

All FDA import refusal data for IOULIA AND IRENE TSETI PHARMACEU 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.