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SSA IV HECHO ENE MX POR LAB

⚠️ Moderate Risk

FEI: 3020609412 • San Andres • MEXICO

FEI

FEI Number

3020609412

📍

Location

San Andres

🇲🇽

Country

MEXICO
🏢

Address

2021 Col Parque, , San Andres, , Mexico

Moderate Risk

FDA Import Risk Assessment

40.8
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
11/8/2021
Latest Refusal
11/8/2021
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
2.5×20%
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

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
11/8/2021
54ACY11HYDROXOCOBALAMIN (VITAMIN)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is SSA IV HECHO ENE MX POR LAB's FDA import refusal history?

SSA IV HECHO ENE MX POR LAB (FEI: 3020609412) has 1 FDA import refusal record(s) in our database, spanning from 11/8/2021 to 11/8/2021.

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. SSA IV HECHO ENE MX POR LAB's FEI number is 3020609412.

What types of violations has SSA IV HECHO ENE MX POR LAB received?

SSA IV HECHO ENE MX POR LAB 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 SSA IV HECHO ENE MX POR LAB come from?

All FDA import refusal data for SSA IV HECHO ENE MX POR LAB 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.