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Grupo Penafiel

⚠️ Moderate Risk

FEI: 3009229778 • Ciudad De Mexico, Ciudad de Mexico • MEXICO

FEI

FEI Number

3009229778

📍

Location

Ciudad De Mexico, Ciudad de Mexico

🇲🇽

Country

MEXICO
🏢

Address

Boulevard Manuel Avila Camacho 32, Col. Lomas De Chapultepec Iii Seccion, Miguel Hidalgo, Ciudad De Mexico, Ciudad de Mexico, Mexico

Moderate Risk

FDA Import Risk Assessment

39.5
LowModerateHighCritical

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

Statistics

2
Total Refusals
3
Unique Violations
8/21/2024
Latest Refusal
12/19/2013
Earliest Refusal

Score Breakdown

Violation Severity
56.7×40%
Refusal Volume
17.7×30%
Recency
56.9×20%
Frequency
1.9×10%
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

2511×

POISONOUS

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a poisonous or deleterious substance which may render the article injurious to health. Contains:

2561×

INCONSPICU

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
8/21/2024
29SHT05MINERAL WATER, CARBONATED WATER (NONMEDICINAL)
251POISONOUS
Division of Southwest Imports (DSWI)
12/19/2013
29SGE05MINERAL WATER, CARBONATED WATER (NONMEDICINAL)
256INCONSPICU
482NUTRIT LBL
Division of Southwest Imports (DSWI)

Frequently Asked Questions

What is Grupo Penafiel's FDA import refusal history?

Grupo Penafiel (FEI: 3009229778) has 2 FDA import refusal record(s) in our database, spanning from 12/19/2013 to 8/21/2024.

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. Grupo Penafiel's FEI number is 3009229778.

What types of violations has Grupo Penafiel received?

Grupo Penafiel 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 Grupo Penafiel come from?

All FDA import refusal data for Grupo Penafiel 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.