Ehticon Endo Surgery

⚠️ Moderate Risk

FEI: 3010730218 • Chihuaha • MEXICO

FEI

FEI Number

3010730218

📍

Location

Chihuaha

🇲🇽

Country

MEXICO

🏢

Address

7125 Colinia Savarcar 118 Cuidad, , Chihuaha, , Mexico

Moderate Risk

FDA Import Risk Assessment

44.0

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

3/27/2023

Latest Refusal

3/27/2023

Earliest Refusal

Score Breakdown

Violation Severity

40.0×40%

Refusal Volume

40.0×30%

Recency

30.0×20%

Frequency

100.0×10%

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

Violation Summary

328011×

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.

34111×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

Refusal History

Date	Product	Violations	Division
3/27/2023	79GDWSTAPLE, IMPLANTABLE	3280FRNMFGREG 341REGISTERED	Division of West Coast Imports (DWCI)
3/27/2023	79GDWSTAPLE, IMPLANTABLE	3280FRNMFGREG 341REGISTERED	Division of West Coast Imports (DWCI)
3/27/2023	79GDWSTAPLE, IMPLANTABLE	3280FRNMFGREG 341REGISTERED	Division of West Coast Imports (DWCI)
3/27/2023	79GDWSTAPLE, IMPLANTABLE	3280FRNMFGREG 341REGISTERED	Division of West Coast Imports (DWCI)
3/27/2023	79GDWSTAPLE, IMPLANTABLE	3280FRNMFGREG 341REGISTERED	Division of West Coast Imports (DWCI)
3/27/2023	79GDWSTAPLE, IMPLANTABLE	3280FRNMFGREG 341REGISTERED	Division of West Coast Imports (DWCI)
3/27/2023	79GDWSTAPLE, IMPLANTABLE	3280FRNMFGREG 341REGISTERED	Division of West Coast Imports (DWCI)
3/27/2023	79GDWSTAPLE, IMPLANTABLE	3280FRNMFGREG 341REGISTERED	Division of West Coast Imports (DWCI)
3/27/2023	79GDWSTAPLE, IMPLANTABLE	3280FRNMFGREG 341REGISTERED	Division of West Coast Imports (DWCI)
3/27/2023	79GDWSTAPLE, IMPLANTABLE	3280FRNMFGREG 341REGISTERED	Division of West Coast Imports (DWCI)
3/27/2023	79GDWSTAPLE, IMPLANTABLE	3280FRNMFGREG 341REGISTERED	Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is Ehticon Endo Surgery's FDA import refusal history?

Ehticon Endo Surgery (FEI: 3010730218) has 11 FDA import refusal record(s) in our database, spanning from 3/27/2023 to 3/27/2023.

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. Ehticon Endo Surgery's FEI number is 3010730218.

What types of violations has Ehticon Endo Surgery received?

Ehticon Endo Surgery has been cited for 2 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 Ehticon Endo Surgery come from?

All FDA import refusal data for Ehticon Endo Surgery 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.