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Vaclavek Radek

⚠️ Moderate Risk

FEI: 3005567012 • Prague 5 • CZECH REPUBLIC

FEI

FEI Number

3005567012

📍

Location

Prague 5

🇨🇿
🏢

Address

Plzenska 795/84, , Prague 5, , Czech Republic

Moderate Risk

FDA Import Risk Assessment

26.4
LowModerateHighCritical

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

Statistics

4
Total Refusals
5
Unique Violations
4/7/2006
Latest Refusal
4/7/2006
Earliest Refusal

Score Breakdown

Violation Severity
36.7×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
40.0×10%
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

3243×

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)).

4823×

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.

4731×

LABELING

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

4741×

COSMETLBLG

It appears the label does not bear the common or usual name of the cosmetic.

4751×

COSMETLBLG

It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.

Refusal History

DateProductViolationsDivision
4/7/2006
53QC99COSMETIC PACKAGING AND LABELING, N.E.C.
473LABELING
474COSMETLBLG
475COSMETLBLG
Chicago District Office (CHI-DO)
4/7/2006
27YHB05MUSTARD, PREPARED
324NO ENGLISH
482NUTRIT LBL
Chicago District Office (CHI-DO)
4/7/2006
26AAB09VIRGIN OLIVE OIL, CRUDE
324NO ENGLISH
482NUTRIT LBL
Chicago District Office (CHI-DO)
4/7/2006
29WHT02BOTTLED SPRING OR MINERAL WATER
324NO ENGLISH
482NUTRIT LBL
Chicago District Office (CHI-DO)

Frequently Asked Questions

What is Vaclavek Radek's FDA import refusal history?

Vaclavek Radek (FEI: 3005567012) has 4 FDA import refusal record(s) in our database, spanning from 4/7/2006 to 4/7/2006.

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. Vaclavek Radek's FEI number is 3005567012.

What types of violations has Vaclavek Radek received?

Vaclavek Radek has been cited for 5 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 Vaclavek Radek come from?

All FDA import refusal data for Vaclavek Radek 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.