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BOLHAR KRYSTSINA

⚠️ Moderate Risk

FEI: 3012580620 • Minsk • BELARUS

FEI

FEI Number

3012580620

📍

Location

Minsk

🇧🇾

Country

BELARUS
🏢

Address

Yakubova 76 2, , Minsk, , Belarus

Moderate Risk

FDA Import Risk Assessment

26.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
8/16/2016
Latest Refusal
8/16/2016
Earliest Refusal

Score Breakdown

Violation Severity
55.0×40%
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)

721×

NEW VET DR

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.

Refusal History

DateProductViolationsDivision
8/16/2016
68YAY10SMALL ANIMAL ANIMAL DRUGS N.E.C.
3260NO ENGLISH
72NEW VET DR
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is BOLHAR KRYSTSINA's FDA import refusal history?

BOLHAR KRYSTSINA (FEI: 3012580620) has 1 FDA import refusal record(s) in our database, spanning from 8/16/2016 to 8/16/2016.

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. BOLHAR KRYSTSINA's FEI number is 3012580620.

What types of violations has BOLHAR KRYSTSINA received?

BOLHAR KRYSTSINA has been cited for 2 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 BOLHAR KRYSTSINA come from?

All FDA import refusal data for BOLHAR KRYSTSINA 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.