ImportRefusal LogoImportRefusal

Alexander Medical Sa De Cv

✅ Low Risk

FEI: 3010917613 • Coacalco de Berriozabal, Mexico • MEXICO

FEI

FEI Number

3010917613

📍

Location

Coacalco de Berriozabal, Mexico

🇲🇽

Country

MEXICO
🏢

Address

Malaquias Huitron Int. No. 60, Parque Industrial Coacalco, Coacalco de Berriozabal, Mexico, Mexico

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
1
Unique Violations
9/3/2014
Latest Refusal
9/3/2014
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
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

1181×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

Refusal History

DateProductViolationsDivision
9/3/2014
87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
118NOT LISTED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Alexander Medical Sa De Cv's FDA import refusal history?

Alexander Medical Sa De Cv (FEI: 3010917613) has 1 FDA import refusal record(s) in our database, spanning from 9/3/2014 to 9/3/2014.

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. Alexander Medical Sa De Cv's FEI number is 3010917613.

What types of violations has Alexander Medical Sa De Cv received?

Alexander Medical 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 Alexander Medical Sa De Cv come from?

All FDA import refusal data for Alexander Medical 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.