Ethicon Endo-Surgery SA de CV, Planta II
⚠️ High Risk
FEI: 3003565435 • Juarez, Chihuahua • MEXICO
FEI Number
3003565435
Location
Juarez, Chihuahua
Country
MEXICOAddress
Calle Durango No. 2751, Col. Parque Industrial Americas, Lote Bravo, Juarez, Chihuahua, Mexico
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
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).
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.
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.
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
DANGEROUS
The article appears to be dangerous to health when used in the dosage or manner, or with the frequency or duration, prescribed, recommended, or suggested in the labeling thereof.
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 |
|---|---|---|---|
| 3/30/2023 | 79LFLINSTRUMENT, ULTRASONIC SURGICAL | Division of West Coast Imports (DWCI) | |
| 3/30/2023 | 79LFLINSTRUMENT, ULTRASONIC SURGICAL | Division of West Coast Imports (DWCI) | |
| 3/30/2023 | 79LFLINSTRUMENT, ULTRASONIC SURGICAL | Division of West Coast Imports (DWCI) | |
| 3/30/2023 | 79LFLINSTRUMENT, ULTRASONIC SURGICAL | Division of West Coast Imports (DWCI) | |
| 3/30/2023 | 79LFLINSTRUMENT, ULTRASONIC SURGICAL | Division of West Coast Imports (DWCI) | |
| 3/30/2023 | 79LFLINSTRUMENT, ULTRASONIC SURGICAL | Division of West Coast Imports (DWCI) | |
| 3/30/2023 | 79LFLINSTRUMENT, ULTRASONIC SURGICAL | Division of West Coast Imports (DWCI) | |
| 3/30/2023 | 79LFLINSTRUMENT, ULTRASONIC SURGICAL | Division of West Coast Imports (DWCI) | |
| 3/30/2023 | 79LFLINSTRUMENT, ULTRASONIC SURGICAL | Division of West Coast Imports (DWCI) | |
| 10/26/2022 | 79LFLINSTRUMENT, ULTRASONIC SURGICAL | 3280FRNMFGREG | Division of Southwest Imports (DSWI) |
| 3/1/2021 | 79LFLINSTRUMENT, ULTRASONIC SURGICAL | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/1/2021 | 79FZPCLIP, IMPLANTABLE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/1/2021 | 79LFLINSTRUMENT, ULTRASONIC SURGICAL | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/1/2021 | 79LFLINSTRUMENT, ULTRASONIC SURGICAL | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/1/2021 | 79LFLINSTRUMENT, ULTRASONIC SURGICAL | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/1/2021 | 79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/1/2021 | 79LFLINSTRUMENT, ULTRASONIC SURGICAL | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/1/2021 | 79LFLINSTRUMENT, ULTRASONIC SURGICAL | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/1/2021 | 79LFLINSTRUMENT, ULTRASONIC SURGICAL | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 9/9/2020 | 79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | 237NO PMA | Division of Southwest Imports (DSWI) |
| 9/9/2020 | 79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | 237NO PMA | Division of Southwest Imports (DSWI) |
| 9/9/2020 | 79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | 237NO PMA | Division of Southwest Imports (DSWI) |
| 9/9/2020 | 79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | 237NO PMA | Division of Southwest Imports (DSWI) |
| 3/8/2019 | 79LFLINSTRUMENT, ULTRASONIC SURGICAL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 6/13/2018 | 79LFLINSTRUMENT, ULTRASONIC SURGICAL | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 5/23/2016 | 79GATSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE | 117DANGEROUS | Southwest Import District Office (SWI-DO) |
| 4/29/2016 | 79GATSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE | 508NO 510(K) | Southwest Import District Office (SWI-DO) |
| 4/20/2016 | 79GATSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE | 508NO 510(K) | Southwest Import District Office (SWI-DO) |
| 11/8/2013 | 79GDWSTAPLE, IMPLANTABLE | New Orleans District Office (NOL-DO) | |
| 11/8/2013 | 79FZPCLIP, IMPLANTABLE | New Orleans District Office (NOL-DO) | |
| 11/8/2013 | 79GCJLAPAROSCOPE, GENERAL & PLASTIC SURGERY | New Orleans District Office (NOL-DO) | |
| 11/8/2013 | 79LFLINSTRUMENT, ULTRASONIC SURGICAL | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Ethicon Endo-Surgery SA de CV, Planta II's FDA import refusal history?
Ethicon Endo-Surgery SA de CV, Planta II (FEI: 3003565435) has 32 FDA import refusal record(s) in our database, spanning from 11/8/2013 to 3/30/2023.
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. Ethicon Endo-Surgery SA de CV, Planta II's FEI number is 3003565435.
What types of violations has Ethicon Endo-Surgery SA de CV, Planta II received?
Ethicon Endo-Surgery SA de CV, Planta II has been cited for 6 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, Planta II come from?
All FDA import refusal data for Ethicon Endo-Surgery SA de CV, Planta II 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.