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ULTRA LAB SA DE CV DR

⚠️ Moderate Risk

FEI: 3020611827 • Guadalajara Jalisco • MEXICO

FEI

FEI Number

3020611827

📍

Location

Guadalajara Jalisco

🇲🇽

Country

MEXICO
🏢

Address

No2910 Col Alamo, , Guadalajara Jalisco, , Mexico

Moderate Risk

FDA Import Risk Assessment

40.8
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
11/8/2021
Latest Refusal
11/8/2021
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
2.5×20%
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

751×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
11/8/2021
62GCA90DICLOFENAC POTASSIUM (ANTI-INFLAMMATORY)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is ULTRA LAB SA DE CV DR's FDA import refusal history?

ULTRA LAB SA DE CV DR (FEI: 3020611827) has 1 FDA import refusal record(s) in our database, spanning from 11/8/2021 to 11/8/2021.

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. ULTRA LAB SA DE CV DR's FEI number is 3020611827.

What types of violations has ULTRA LAB SA DE CV DR received?

ULTRA LAB SA DE CV DR 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 ULTRA LAB SA DE CV DR come from?

All FDA import refusal data for ULTRA LAB SA DE CV DR 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.