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Kofola A.S.

⚠️ Moderate Risk

FEI: 3004058731 • Krnov, Moravskoslezsky Kraj • CZECH REPUBLIC

FEI

FEI Number

3004058731

📍

Location

Krnov, Moravskoslezsky Kraj

🇨🇿
🏢

Address

Za Drahou 165/1, , Krnov, Moravskoslezsky Kraj, Czech Republic

Moderate Risk

FDA Import Risk Assessment

33.3
LowModerateHighCritical

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

Statistics

8
Total Refusals
3
Unique Violations
7/30/2012
Latest Refusal
7/30/2012
Earliest Refusal

Score Breakdown

Violation Severity
36.7×40%
Refusal Volume
35.3×30%
Recency
0.0×20%
Frequency
80.0×10%
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

3248×

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)).

4738×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

4828×

NUTRIT LBL

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.

Refusal History

DateProductViolationsDivision
7/30/2012
30BHE04BEVERAGE BASE, MIXED FRUIT, LIQUID
324NO ENGLISH
473LABELING
482NUTRIT LBL
Seattle District Office (SEA-DO)
7/30/2012
30BHE02BEVERAGE BASE, CITRUS, LIQUID
324NO ENGLISH
473LABELING
482NUTRIT LBL
Seattle District Office (SEA-DO)
7/30/2012
30BHE04BEVERAGE BASE, MIXED FRUIT, LIQUID
324NO ENGLISH
473LABELING
482NUTRIT LBL
Seattle District Office (SEA-DO)
7/30/2012
29BHE50SOFT DRINK, COLA, CARBONATED
324NO ENGLISH
473LABELING
482NUTRIT LBL
Seattle District Office (SEA-DO)
7/30/2012
29BHE50SOFT DRINK, COLA, CARBONATED
324NO ENGLISH
473LABELING
482NUTRIT LBL
Seattle District Office (SEA-DO)
7/30/2012
29BHE09SOFT DRINK, OTHER FRUIT FLAVORED, CARBONATED
324NO ENGLISH
473LABELING
482NUTRIT LBL
Seattle District Office (SEA-DO)
7/30/2012
29BHE09SOFT DRINK, OTHER FRUIT FLAVORED, CARBONATED
324NO ENGLISH
473LABELING
482NUTRIT LBL
Seattle District Office (SEA-DO)
7/30/2012
29BHE50SOFT DRINK, COLA, CARBONATED
324NO ENGLISH
473LABELING
482NUTRIT LBL
Seattle District Office (SEA-DO)

Frequently Asked Questions

What is Kofola A.S.'s FDA import refusal history?

Kofola A.S. (FEI: 3004058731) has 8 FDA import refusal record(s) in our database, spanning from 7/30/2012 to 7/30/2012.

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. Kofola A.S.'s FEI number is 3004058731.

What types of violations has Kofola A.S. received?

Kofola A.S. has been cited for 3 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 Kofola A.S. come from?

All FDA import refusal data for Kofola A.S. 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.