ImportRefusal LogoImportRefusal

COMASDA

⚠️ High Risk

FEI: 3032058654 • Degollado • MEXICO

FEI

FEI Number

3032058654

📍

Location

Degollado

🇲🇽

Country

MEXICO
🏢

Address

Camino A Los Arr Km 3.5, , Degollado, , Mexico

High Risk

FDA Import Risk Assessment

51.1
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

2
Total Refusals
1
Unique Violations
9/25/2024
Latest Refusal
9/25/2024
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
17.7×30%
Recency
58.8×20%
Frequency
20.0×10%
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

722×

NEW VET DR

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.

Refusal History

DateProductViolationsDivision
9/25/2024
66VCY99MISCELLANEOUS PATENT MEDICINES, ETC.
72NEW VET DR
Division of Southeast Imports (DSEI)
9/25/2024
62LDY47IVERMECTIN (ANTI-PROTOZOAL, A-LEISHMANIAL, ANTI-MALARIAL)
72NEW VET DR
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is COMASDA's FDA import refusal history?

COMASDA (FEI: 3032058654) has 2 FDA import refusal record(s) in our database, spanning from 9/25/2024 to 9/25/2024.

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. COMASDA's FEI number is 3032058654.

What types of violations has COMASDA received?

COMASDA 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 COMASDA come from?

All FDA import refusal data for COMASDA 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.