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Biotex Ltd

⚠️ Moderate Risk

FEI: 3011628844 • Sofia, Sofia • BULGARIA

FEI

FEI Number

3011628844

📍

Location

Sofia, Sofia

🇧🇬

Country

BULGARIA
🏢

Address

Ul.Starozagorsko Vastanie 34a, , Sofia, Sofia, Bulgaria

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

1
Total Refusals
1
Unique Violations
9/9/2015
Latest Refusal
9/9/2015
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
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
9/9/2015
54YCE99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is Biotex Ltd's FDA import refusal history?

Biotex Ltd (FEI: 3011628844) has 1 FDA import refusal record(s) in our database, spanning from 9/9/2015 to 9/9/2015.

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. Biotex Ltd's FEI number is 3011628844.

What types of violations has Biotex Ltd received?

Biotex Ltd 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 Biotex Ltd come from?

All FDA import refusal data for Biotex Ltd 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.