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FUEGO ENVASADO SA DE CV

⚠️ Moderate Risk

FEI: 3017504712 • Morelos • MEXICO

FEI

FEI Number

3017504712

📍

Location

Morelos

🇲🇽

Country

MEXICO
🏢

Address

Esfuerzo Nacional Cp 7, , Morelos, , Mexico

Moderate Risk

FDA Import Risk Assessment

39.9
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
8/12/2022
Latest Refusal
8/12/2022
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
11.2×30%
Recency
17.6×20%
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

271×

DRUG GMPS

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).

Refusal History

DateProductViolationsDivision
8/12/2022
62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL)
27DRUG GMPS
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is FUEGO ENVASADO SA DE CV's FDA import refusal history?

FUEGO ENVASADO SA DE CV (FEI: 3017504712) has 1 FDA import refusal record(s) in our database, spanning from 8/12/2022 to 8/12/2022.

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. FUEGO ENVASADO SA DE CV's FEI number is 3017504712.

What types of violations has FUEGO ENVASADO SA DE CV received?

FUEGO ENVASADO 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 FUEGO ENVASADO SA DE CV come from?

All FDA import refusal data for FUEGO ENVASADO 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.