ImportRefusal LogoImportRefusal

Biosintez

✅ Low Risk

FEI: 3006949095 • Penzenskaya Oblast • RUSSIA

FEI

FEI Number

3006949095

📍

Location

Penzenskaya Oblast

🇷🇺

Country

RUSSIA
🏢

Address

Druzjba Street 4, , Penzenskaya Oblast, , Russia

Low Risk

FDA Import Risk Assessment

16.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
1
Unique Violations
9/16/2010
Latest Refusal
9/16/2010
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
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

32601×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)

Refusal History

DateProductViolationsDivision
9/16/2010
54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
3260NO ENGLISH
New York District Office (NYK-DO)

Frequently Asked Questions

What is Biosintez's FDA import refusal history?

Biosintez (FEI: 3006949095) has 1 FDA import refusal record(s) in our database, spanning from 9/16/2010 to 9/16/2010.

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. Biosintez's FEI number is 3006949095.

What types of violations has Biosintez received?

Biosintez 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 Biosintez come from?

All FDA import refusal data for Biosintez 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.