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PRODUCTOS FARMACEUTICOS EDERKA S

⚠️ High Risk

FEI: 3031403403 • Queretaro • MEXICO

FEI

FEI Number

3031403403

📍

Location

Queretaro

🇲🇽

Country

MEXICO
🏢

Address

Planta Calle 3 No 1 Fra, , Queretaro, , Mexico

High Risk

FDA Import Risk Assessment

54.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
7/12/2024
Latest Refusal
7/12/2024
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
69.7×20%
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
7/12/2024
62GDY99ANTI-INFLAMMATORY N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is PRODUCTOS FARMACEUTICOS EDERKA S's FDA import refusal history?

PRODUCTOS FARMACEUTICOS EDERKA S (FEI: 3031403403) has 1 FDA import refusal record(s) in our database, spanning from 7/12/2024 to 7/12/2024.

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. PRODUCTOS FARMACEUTICOS EDERKA S's FEI number is 3031403403.

What types of violations has PRODUCTOS FARMACEUTICOS EDERKA S received?

PRODUCTOS FARMACEUTICOS EDERKA S 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 PRODUCTOS FARMACEUTICOS EDERKA S come from?

All FDA import refusal data for PRODUCTOS FARMACEUTICOS EDERKA S 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.