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ASESORIA Y DESSARROLO DE PROCTOS

⚠️ Moderate Risk

FEI: 3030484946 • Jalisco, COL • MEXICO

FEI

FEI Number

3030484946

📍

Location

Jalisco, COL

🇲🇽

Country

MEXICO
🏢

Address

Carlos Dickens 285, , Jalisco, COL, Mexico

Moderate Risk

FDA Import Risk Assessment

41.0
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
3/21/2024
Latest Refusal
3/21/2024
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
11.2×30%
Recency
63.4×20%
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

4721×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).

751×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
3/21/2024
41BYY99FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS
472NO ENGLISH
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is ASESORIA Y DESSARROLO DE PROCTOS's FDA import refusal history?

ASESORIA Y DESSARROLO DE PROCTOS (FEI: 3030484946) has 1 FDA import refusal record(s) in our database, spanning from 3/21/2024 to 3/21/2024.

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. ASESORIA Y DESSARROLO DE PROCTOS's FEI number is 3030484946.

What types of violations has ASESORIA Y DESSARROLO DE PROCTOS received?

ASESORIA Y DESSARROLO DE PROCTOS 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 ASESORIA Y DESSARROLO DE PROCTOS come from?

All FDA import refusal data for ASESORIA Y DESSARROLO DE PROCTOS 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.