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Comercializadora Inter Home Sa De Cv

✅ Low Risk

FEI: 3011522059 • Reynosa, Tamaulipas • MEXICO

FEI

FEI Number

3011522059

📍

Location

Reynosa, Tamaulipas

🇲🇽

Country

MEXICO
🏢

Address

Calle Luis Donaldo Colosio # 1014-C, Col. Mano Con Mano, Reynosa, Reynosa, Tamaulipas, Mexico

Low Risk

FDA Import Risk Assessment

20.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
6/12/2015
Latest Refusal
6/12/2015
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
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).

3411×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

Refusal History

DateProductViolationsDivision
6/12/2015
76EFWTOOTHBRUSH, MANUAL
118NOT LISTED
341REGISTERED
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is Comercializadora Inter Home Sa De Cv's FDA import refusal history?

Comercializadora Inter Home Sa De Cv (FEI: 3011522059) has 1 FDA import refusal record(s) in our database, spanning from 6/12/2015 to 6/12/2015.

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. Comercializadora Inter Home Sa De Cv's FEI number is 3011522059.

What types of violations has Comercializadora Inter Home Sa De Cv received?

Comercializadora Inter Home Sa De Cv 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 Comercializadora Inter Home Sa De Cv come from?

All FDA import refusal data for Comercializadora Inter Home 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.