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Warner Lambert Mexico S.A. De Cv

⚠️ Moderate Risk

FEI: 1000583170 • Ciudad De Mexico, Ciudad de Mexico • MEXICO

FEI

FEI Number

1000583170

📍

Location

Ciudad De Mexico, Ciudad de Mexico

🇲🇽

Country

MEXICO
🏢

Address

Avenida Division Del Norte 3443, Pueblo San Pablo Tepetlapa, Coyoacan, Ciudad De Mexico, Ciudad de Mexico, Mexico

Moderate Risk

FDA Import Risk Assessment

42.8
LowModerateHighCritical

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

Statistics

5
Total Refusals
2
Unique Violations
2/18/2003
Latest Refusal
2/18/2003
Earliest Refusal

Score Breakdown

Violation Severity
72.9×40%
Refusal Volume
28.8×30%
Recency
0.0×20%
Frequency
50.0×10%
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

115×

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).

3242×

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
2/18/2003
33UGT02CHEWING GUM (WITHOUT CHOCOLATE)
11UNSAFE COL
324NO ENGLISH
Southwest Import District Office (SWI-DO)
2/18/2003
33UGT02CHEWING GUM (WITHOUT CHOCOLATE)
11UNSAFE COL
324NO ENGLISH
Southwest Import District Office (SWI-DO)
2/18/2003
33UGT02CHEWING GUM (WITHOUT CHOCOLATE)
11UNSAFE COL
Southwest Import District Office (SWI-DO)
2/18/2003
33UGT02CHEWING GUM (WITHOUT CHOCOLATE)
11UNSAFE COL
Southwest Import District Office (SWI-DO)
2/18/2003
33UGT02CHEWING GUM (WITHOUT CHOCOLATE)
11UNSAFE COL
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is Warner Lambert Mexico S.A. De Cv's FDA import refusal history?

Warner Lambert Mexico S.A. De Cv (FEI: 1000583170) has 5 FDA import refusal record(s) in our database, spanning from 2/18/2003 to 2/18/2003.

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. Warner Lambert Mexico S.A. De Cv's FEI number is 1000583170.

What types of violations has Warner Lambert Mexico S.A. De Cv received?

Warner Lambert Mexico S.A. De Cv has been cited for 2 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 Warner Lambert Mexico S.A. De Cv come from?

All FDA import refusal data for Warner Lambert Mexico S.A. De Cv 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.