Ethicon Endo-surgery SA de CV
⚠️ Moderate Risk
FEI: 3003131758 • Juarez • MEXICO
FEI Number
3003131758
Location
Juarez
Country
MEXICOAddress
Avenida de Las Torres No. 7125, Col. SALVARCAR, Juarez, , Mexico
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
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.
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
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 |
|---|---|---|---|
| 5/1/2025 | 79GDWSTAPLE, IMPLANTABLE | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 11/14/2024 | 79GDWSTAPLE, IMPLANTABLE | Division of West Coast Imports (DWCI) | |
| 9/20/2024 | 79GDWSTAPLE, IMPLANTABLE | Division of Southeast Imports (DSEI) | |
| 9/20/2024 | 79GDWSTAPLE, IMPLANTABLE | Division of Southeast Imports (DSEI) | |
| 6/17/2022 | 79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | Division of Southeast Imports (DSEI) | |
| 6/7/2022 | 79GDWSTAPLE, IMPLANTABLE | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 6/7/2022 | 79GDWSTAPLE, IMPLANTABLE | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 4/23/2020 | 79GDWSTAPLE, IMPLANTABLE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 11/8/2013 | 79GCJLAPAROSCOPE, GENERAL & PLASTIC SURGERY | New Orleans District Office (NOL-DO) | |
| 11/8/2013 | 79GDWSTAPLE, IMPLANTABLE | New Orleans District Office (NOL-DO) | |
| 11/8/2013 | 79GDWSTAPLE, IMPLANTABLE | New Orleans District Office (NOL-DO) | |
| 11/8/2013 | 79GDWSTAPLE, IMPLANTABLE | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Ethicon Endo-surgery SA de CV's FDA import refusal history?
Ethicon Endo-surgery SA de CV (FEI: 3003131758) has 12 FDA import refusal record(s) in our database, spanning from 11/8/2013 to 5/1/2025.
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 SA de CV's FEI number is 3003131758.
What types of violations has Ethicon Endo-surgery SA de CV received?
Ethicon Endo-surgery SA de CV has been cited for 4 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 SA de CV come from?
All FDA import refusal data for Ethicon Endo-surgery 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.