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Tymbark-MWS Sp. z o.o. S.K.A

⚠️ Moderate Risk

FEI: 3004275149 • Tymbark, Malopolskie • POLAND

FEI

FEI Number

3004275149

📍

Location

Tymbark, Malopolskie

🇵🇱

Country

POLAND
🏢

Address

Ul. Tymbark 156, , Tymbark, Malopolskie, Poland

Moderate Risk

FDA Import Risk Assessment

29.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
4
Unique Violations
11/13/2012
Latest Refusal
11/13/2012
Earliest Refusal

Score Breakdown

Violation Severity
62.5×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

111×

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).

26401×

CYCLAMATE

The article appears to bear or contain cyclamate, an unsafe food additive within the meaning of Section 409

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)).

4821×

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
11/13/2012
29YGT99SOFT DRINKS AND WATERS NOT MENTIONED ELSEWHERE, N.E.C.
11UNSAFE COL
2640CYCLAMATE
324NO ENGLISH
482NUTRIT LBL
New York District Office (NYK-DO)

Frequently Asked Questions

What is Tymbark-MWS Sp. z o.o. S.K.A's FDA import refusal history?

Tymbark-MWS Sp. z o.o. S.K.A (FEI: 3004275149) has 1 FDA import refusal record(s) in our database, spanning from 11/13/2012 to 11/13/2012.

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. Tymbark-MWS Sp. z o.o. S.K.A's FEI number is 3004275149.

What types of violations has Tymbark-MWS Sp. z o.o. S.K.A received?

Tymbark-MWS Sp. z o.o. S.K.A 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 Tymbark-MWS Sp. z o.o. S.K.A come from?

All FDA import refusal data for Tymbark-MWS Sp. z o.o. S.K.A 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.