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ETHICON ENDO-SURGERY S.A. DE C.VAVENIDA DE LAS TOR

⚠️ Moderate Risk

FEI: 3015163983 • Cd. Juarez • MEXICO

FEI

FEI Number

3015163983

📍

Location

Cd. Juarez

🇲🇽

Country

MEXICO
🏢

Address

7125 Colonia Sa, , Cd. Juarez, , Mexico

Moderate Risk

FDA Import Risk Assessment

28.6
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
5/11/2021
Latest Refusal
10/24/2019
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
19.4×10%
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

32803×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

Refusal History

DateProductViolationsDivision
5/11/2021
79GDWSTAPLE, IMPLANTABLE
3280FRNMFGREG
Division of Southeast Imports (DSEI)
5/11/2021
79GDWSTAPLE, IMPLANTABLE
3280FRNMFGREG
Division of Southeast Imports (DSEI)
10/24/2019
79GDWSTAPLE, IMPLANTABLE
3280FRNMFGREG
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is ETHICON ENDO-SURGERY S.A. DE C.VAVENIDA DE LAS TOR's FDA import refusal history?

ETHICON ENDO-SURGERY S.A. DE C.VAVENIDA DE LAS TOR (FEI: 3015163983) has 3 FDA import refusal record(s) in our database, spanning from 10/24/2019 to 5/11/2021.

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. ETHICON ENDO-SURGERY S.A. DE C.VAVENIDA DE LAS TOR's FEI number is 3015163983.

What types of violations has ETHICON ENDO-SURGERY S.A. DE C.VAVENIDA DE LAS TOR received?

ETHICON ENDO-SURGERY S.A. DE C.VAVENIDA DE LAS TOR 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 ETHICON ENDO-SURGERY S.A. DE C.VAVENIDA DE LAS TOR come from?

All FDA import refusal data for ETHICON ENDO-SURGERY S.A. DE C.VAVENIDA DE LAS TOR 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.