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Comercializadora Rya De Reynosa,Sa Decv

✅ Low Risk

FEI: 3004022544 • Reynosa, Tamaulipas • MEXICO

FEI

FEI Number

3004022544

📍

Location

Reynosa, Tamaulipas

🇲🇽

Country

MEXICO
🏢

Address

Boulevard Del Maestro 125., Col. LAS CUMBRES, Reynosa, Tamaulipas, 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
3
Unique Violations
11/7/2003
Latest Refusal
11/7/2003
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).

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).

471×

NON STD

The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.

Refusal History

DateProductViolationsDivision
11/7/2003
80LDQDEVICE, GENERAL MEDICAL
118NOT LISTED
341REGISTERED
47NON STD
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is Comercializadora Rya De Reynosa,Sa Decv's FDA import refusal history?

Comercializadora Rya De Reynosa,Sa Decv (FEI: 3004022544) has 1 FDA import refusal record(s) in our database, spanning from 11/7/2003 to 11/7/2003.

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 Rya De Reynosa,Sa Decv's FEI number is 3004022544.

What types of violations has Comercializadora Rya De Reynosa,Sa Decv received?

Comercializadora Rya De Reynosa,Sa Decv has been cited for 3 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 Rya De Reynosa,Sa Decv come from?

All FDA import refusal data for Comercializadora Rya De Reynosa,Sa Decv 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.