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Productos Alimentacion y Dieteticos Relampago SA de CV

⚠️ Moderate Risk

FEI: 3002570697 • Ciudad De Mexico, Ciudad de Mexico • MEXICO

FEI

FEI Number

3002570697

📍

Location

Ciudad De Mexico, Ciudad de Mexico

🇲🇽

Country

MEXICO
🏢

Address

Avenida Calzada De Tlalpan # 5161, Col. La Joya, Tlalpan, Ciudad De Mexico, Ciudad de Mexico, Mexico

Moderate Risk

FDA Import Risk Assessment

27.4
LowModerateHighCritical

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

Statistics

6
Total Refusals
1
Unique Violations
7/13/2016
Latest Refusal
7/13/2016
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
Refusal Volume
31.3×30%
Recency
0.0×20%
Frequency
60.0×10%
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

3246×

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
7/13/2016
35AGT01GELATIN, FLAVORED
324NO ENGLISH
Division of Northeast Imports (DNEI)
7/13/2016
35AGT01GELATIN, FLAVORED
324NO ENGLISH
Division of Northeast Imports (DNEI)
7/13/2016
35AGT01GELATIN, FLAVORED
324NO ENGLISH
Division of Northeast Imports (DNEI)
7/13/2016
35AGT01GELATIN, FLAVORED
324NO ENGLISH
Division of Northeast Imports (DNEI)
7/13/2016
35AGT01GELATIN, FLAVORED
324NO ENGLISH
Division of Northeast Imports (DNEI)
7/13/2016
35AGT01GELATIN, FLAVORED
324NO ENGLISH
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is Productos Alimentacion y Dieteticos Relampago SA de CV's FDA import refusal history?

Productos Alimentacion y Dieteticos Relampago SA de CV (FEI: 3002570697) has 6 FDA import refusal record(s) in our database, spanning from 7/13/2016 to 7/13/2016.

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. Productos Alimentacion y Dieteticos Relampago SA de CV's FEI number is 3002570697.

What types of violations has Productos Alimentacion y Dieteticos Relampago SA de CV received?

Productos Alimentacion y Dieteticos Relampago SA de CV has been cited for 1 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 Productos Alimentacion y Dieteticos Relampago SA de CV come from?

All FDA import refusal data for Productos Alimentacion y Dieteticos Relampago SA 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.