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LABORATORIOS DB SA DE CV

⚠️ Moderate Risk

FEI: 3026118017 • San Salvador • EL SALVADOR

FEI

FEI Number

3026118017

📍

Location

San Salvador

🇸🇻
🏢

Address

Pq56 424, , San Salvador, , El Salvador

Moderate Risk

FDA Import Risk Assessment

46.0
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
2/27/2023
Latest Refusal
2/27/2023
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
28.6×20%
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
2/27/2023
61WCJ04CLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

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

LABORATORIOS DB SA DE CV (FEI: 3026118017) has 1 FDA import refusal record(s) in our database, spanning from 2/27/2023 to 2/27/2023.

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. LABORATORIOS DB SA DE CV's FEI number is 3026118017.

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

LABORATORIOS DB 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 LABORATORIOS DB SA DE CV come from?

All FDA import refusal data for LABORATORIOS DB 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.