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Comercializadora Gorega, Sa De Cv

⚠️ Moderate Risk

FEI: 3004992016 • Edo De M • MEXICO

FEI

FEI Number

3004992016

📍

Location

Edo De M

🇲🇽

Country

MEXICO
🏢

Address

Paraje Capulin S/N Barrio De Sta., , Municipio De Otzolotepec, Edo De M, , Mexico

Moderate Risk

FDA Import Risk Assessment

36.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
3/15/2005
Latest Refusal
3/15/2005
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
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

831×

NO PROCESS

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.

Refusal History

DateProductViolationsDivision
3/15/2005
25RCE99MUSHROOMS AND OTHER FUNGI PRODUCTS, BROKEN OR KIBBLED, N.E.C.
83NO PROCESS
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is Comercializadora Gorega, Sa De Cv's FDA import refusal history?

Comercializadora Gorega, Sa De Cv (FEI: 3004992016) has 1 FDA import refusal record(s) in our database, spanning from 3/15/2005 to 3/15/2005.

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 Gorega, Sa De Cv's FEI number is 3004992016.

What types of violations has Comercializadora Gorega, Sa De Cv received?

Comercializadora Gorega, 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 Comercializadora Gorega, Sa De Cv come from?

All FDA import refusal data for Comercializadora Gorega, 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.