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Mondelez Bulgaria Production OOD

⚠️ Moderate Risk

FEI: 3010131370 • Kazichene, oblast Sofiya grad • BULGARIA

FEI

FEI Number

3010131370

📍

Location

Kazichene, oblast Sofiya grad

🇧🇬

Country

BULGARIA
🏢

Address

Ulitsa Serafim Stoev 6, Village, Kazichene, oblast Sofiya grad, Bulgaria

Moderate Risk

FDA Import Risk Assessment

29.0
LowModerateHighCritical

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

Statistics

7
Total Refusals
1
Unique Violations
2/10/2012
Latest Refusal
2/10/2012
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
Refusal Volume
33.5×30%
Recency
0.0×20%
Frequency
70.0×10%
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

3247×

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
03AYT14CROISSANT BREAD/ROLLS
324NO ENGLISH
New York District Office (NYK-DO)
2/10/2012
03MGT99COOKIE,BISCUIT,WAFER DOUGH, N.E.C.
324NO ENGLISH
New York District Office (NYK-DO)
2/10/2012
03AYT14CROISSANT BREAD/ROLLS
324NO ENGLISH
New York District Office (NYK-DO)
2/10/2012
03RGT01CAKE WITHOUT CUSTARD OR CREAM FILLING
324NO ENGLISH
New York District Office (NYK-DO)
2/10/2012
03RGT01CAKE WITHOUT CUSTARD OR CREAM FILLING
324NO ENGLISH
New York District Office (NYK-DO)
2/10/2012
03RGT01CAKE WITHOUT CUSTARD OR CREAM FILLING
324NO ENGLISH
New York District Office (NYK-DO)
2/10/2012
34YGE99CHOCOLATE AND COCOA PRODUCTS, N.E.C.
324NO ENGLISH
New York District Office (NYK-DO)

Frequently Asked Questions

What is Mondelez Bulgaria Production OOD's FDA import refusal history?

Mondelez Bulgaria Production OOD (FEI: 3010131370) has 7 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. Mondelez Bulgaria Production OOD's FEI number is 3010131370.

What types of violations has Mondelez Bulgaria Production OOD received?

Mondelez Bulgaria Production OOD 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 Mondelez Bulgaria Production OOD come from?

All FDA import refusal data for Mondelez Bulgaria Production OOD 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.