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JSC ODESSAKONDITER

⚠️ Moderate Risk

FEI: 3011306938 • Odessa, Odesa Regions • UKRAINE

FEI

FEI Number

3011306938

📍

Location

Odessa, Odesa Regions

🇺🇦

Country

UKRAINE
🏢

Address

9, 3-Rd Vodoprovodny Lane, 9, 3-Rd Vodoprovodny Lane, Odessa, Odesa Regions, Ukraine

Moderate Risk

FDA Import Risk Assessment

33.4
LowModerateHighCritical

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

Statistics

4
Total Refusals
4
Unique Violations
10/12/2012
Latest Refusal
7/1/2008
Earliest Refusal

Score Breakdown

Violation Severity
61.7×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
9.3×10%
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

112×

UNSAFE COL

The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).

642×

YELLOW #5

The food appears to bear or contain the color additive FD & C Yellow No. 5, which is not declared on the label per 21 CFR 74.705(a)(c) under section 721.

2181×

LIST INGRE

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(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.

3241×

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
10/12/2012
03HFT99PLAIN COOKIES,BISCUITS AND WAFERS, N.E.C.
218LIST INGRE
324NO ENGLISH
New York District Office (NYK-DO)
7/1/2008
33EYT02CARAMEL CANDY PIECES, HARD, WITHOUT NUTS OR FRUIT (WITHOUT CHOCOLATE)
64YELLOW #5
Chicago District Office (CHI-DO)
7/1/2008
33EGT99HARD CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
64YELLOW #5
Chicago District Office (CHI-DO)
7/1/2008
33LFT99SOFT CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
Chicago District Office (CHI-DO)

Frequently Asked Questions

What is JSC ODESSAKONDITER's FDA import refusal history?

JSC ODESSAKONDITER (FEI: 3011306938) has 4 FDA import refusal record(s) in our database, spanning from 7/1/2008 to 10/12/2012.

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. JSC ODESSAKONDITER's FEI number is 3011306938.

What types of violations has JSC ODESSAKONDITER received?

JSC ODESSAKONDITER has been cited for 4 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 JSC ODESSAKONDITER come from?

All FDA import refusal data for JSC ODESSAKONDITER 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.