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Hecho En Mexico Por

⚠️ Moderate Risk

FEI: 3006197803 • Guadlajara Jali • MEXICO

FEI

FEI Number

3006197803

📍

Location

Guadlajara Jali

🇲🇽

Country

MEXICO
🏢

Address

Av Hidai Go 1337 S H, , Guadlajara Jali, , Mexico

Moderate Risk

FDA Import Risk Assessment

45.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
11/25/2011
Latest Refusal
11/25/2011
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

753×

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
11/25/2011
62KCA10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL)
75UNAPPROVED
New Orleans District Office (NOL-DO)
11/25/2011
62KCA01DIFENOXIMIDE HCL (ANTI-PERISTALTIC)
75UNAPPROVED
New Orleans District Office (NOL-DO)
11/25/2011
61FCA54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC)
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Hecho En Mexico Por's FDA import refusal history?

Hecho En Mexico Por (FEI: 3006197803) has 3 FDA import refusal record(s) in our database, spanning from 11/25/2011 to 11/25/2011.

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. Hecho En Mexico Por's FEI number is 3006197803.

What types of violations has Hecho En Mexico Por received?

Hecho En Mexico Por 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 Hecho En Mexico Por come from?

All FDA import refusal data for Hecho En Mexico Por 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.