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Bioset

⚠️ Moderate Risk

FEI: 3009918555 • Plovdiv, Plovdiv • BULGARIA

FEI

FEI Number

3009918555

📍

Location

Plovdiv, Plovdiv

🇧🇬

Country

BULGARIA
🏢

Address

Kuklensko Shosse 28 Street, , Plovdiv, Plovdiv, Bulgaria

Moderate Risk

FDA Import Risk Assessment

37.3
LowModerateHighCritical

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

Statistics

23
Total Refusals
1
Unique Violations
2/10/2012
Latest Refusal
2/10/2012
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
Refusal Volume
51.1×30%
Recency
0.0×20%
Frequency
100.0×10%
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

32423×

NO ENGLISH

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).

Refusal History

DateProductViolationsDivision
2/10/2012
38PYY28MIXED VEGETABLE BROTH, DRIED
324NO ENGLISH
New York District Office (NYK-DO)
2/10/2012
38PYY28MIXED VEGETABLE BROTH, DRIED
324NO ENGLISH
New York District Office (NYK-DO)
2/10/2012
38PYY28MIXED VEGETABLE BROTH, DRIED
324NO ENGLISH
New York District Office (NYK-DO)
2/10/2012
38PYY28MIXED VEGETABLE BROTH, DRIED
324NO ENGLISH
New York District Office (NYK-DO)
2/10/2012
38PYY28MIXED VEGETABLE BROTH, DRIED
324NO ENGLISH
New York District Office (NYK-DO)
2/10/2012
38PYY28MIXED VEGETABLE BROTH, DRIED
324NO ENGLISH
New York District Office (NYK-DO)
2/10/2012
38PYY28MIXED VEGETABLE BROTH, DRIED
324NO ENGLISH
New York District Office (NYK-DO)
2/10/2012
38PYY28MIXED VEGETABLE BROTH, DRIED
324NO ENGLISH
New York District Office (NYK-DO)
2/10/2012
38PYY28MIXED VEGETABLE BROTH, DRIED
324NO ENGLISH
New York District Office (NYK-DO)
2/10/2012
28EGE99MIXED SPICE AND SEAONINGS, WITHOUT SALT, N.E.C.
324NO ENGLISH
New York District Office (NYK-DO)
2/10/2012
28EGE99MIXED SPICE AND SEAONINGS, WITHOUT SALT, N.E.C.
324NO ENGLISH
New York District Office (NYK-DO)
2/10/2012
28EGE99MIXED SPICE AND SEAONINGS, WITHOUT SALT, N.E.C.
324NO ENGLISH
New York District Office (NYK-DO)
2/10/2012
28EGE99MIXED SPICE AND SEAONINGS, WITHOUT SALT, N.E.C.
324NO ENGLISH
New York District Office (NYK-DO)
2/10/2012
28EGE99MIXED SPICE AND SEAONINGS, WITHOUT SALT, N.E.C.
324NO ENGLISH
New York District Office (NYK-DO)
2/10/2012
28EGE99MIXED SPICE AND SEAONINGS, WITHOUT SALT, N.E.C.
324NO ENGLISH
New York District Office (NYK-DO)
2/10/2012
28EGE99MIXED SPICE AND SEAONINGS, WITHOUT SALT, N.E.C.
324NO ENGLISH
New York District Office (NYK-DO)
2/10/2012
28EGE99MIXED SPICE AND SEAONINGS, WITHOUT SALT, N.E.C.
324NO ENGLISH
New York District Office (NYK-DO)
2/10/2012
28EGE99MIXED SPICE AND SEAONINGS, WITHOUT SALT, N.E.C.
324NO ENGLISH
New York District Office (NYK-DO)
2/10/2012
28EGE99MIXED SPICE AND SEAONINGS, WITHOUT SALT, N.E.C.
324NO ENGLISH
New York District Office (NYK-DO)
2/10/2012
28EGE99MIXED SPICE AND SEAONINGS, WITHOUT SALT, N.E.C.
324NO ENGLISH
New York District Office (NYK-DO)
2/10/2012
28EGE99MIXED SPICE AND SEAONINGS, WITHOUT SALT, N.E.C.
324NO ENGLISH
New York District Office (NYK-DO)
2/10/2012
28EGE99MIXED SPICE AND SEAONINGS, WITHOUT SALT, N.E.C.
324NO ENGLISH
New York District Office (NYK-DO)
2/10/2012
05YFH99CEREAL PREPARATIONS NOT ELSEWHERE MENTIONED, N.E.C.
324NO ENGLISH
New York District Office (NYK-DO)

Frequently Asked Questions

What is Bioset's FDA import refusal history?

Bioset (FEI: 3009918555) has 23 FDA import refusal record(s) in our database, spanning from 2/10/2012 to 2/10/2012.

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. Bioset's FEI number is 3009918555.

What types of violations has Bioset received?

Bioset 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 Bioset come from?

All FDA import refusal data for Bioset 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.