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SULTRA LABORATORIOS SA DE CV

⚠️ Moderate Risk

FEI: 3017377251 • Jalisco • MEXICO

FEI

FEI Number

3017377251

📍

Location

Jalisco

🇲🇽

Country

MEXICO
🏢

Address

Dr Roberto Michel No 29, , Jalisco, , Mexico

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
11/12/2020
Latest Refusal
11/12/2020
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
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

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
11/12/2020
62GCB90DICLOFENAC POTASSIUM (ANTI-INFLAMMATORY)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is SULTRA LABORATORIOS SA DE CV's FDA import refusal history?

SULTRA LABORATORIOS SA DE CV (FEI: 3017377251) has 1 FDA import refusal record(s) in our database, spanning from 11/12/2020 to 11/12/2020.

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. SULTRA LABORATORIOS SA DE CV's FEI number is 3017377251.

What types of violations has SULTRA LABORATORIOS SA DE CV received?

SULTRA LABORATORIOS 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 SULTRA LABORATORIOS SA DE CV come from?

All FDA import refusal data for SULTRA LABORATORIOS 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.