Ethicon Sarl, a Johnson & Johnson Company
⚠️ Moderate Risk
FEI: 3003702646 • Neuchatel, Republique Et Canton De Neucha • SWITZERLAND
FEI Number
3003702646
Location
Neuchatel, Republique Et Canton De Neucha
Country
SWITZERLANDAddress
Rue Du Puits-godet 20, , Neuchatel, Republique Et Canton De Neucha, Switzerland
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
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.
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 |
|---|---|---|---|
| 2/19/2025 | 79LFLINSTRUMENT, ULTRASONIC SURGICAL | Division of West Coast Imports (DWCI) | |
| 12/11/2008 | 87HWCSCREW, FIXATION, BONE | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 12/11/2008 | 87JDRSTAPLE, FIXATION, BONE | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 12/11/2008 | 87HWCSCREW, FIXATION, BONE | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 12/11/2008 | 87MAIFASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 12/11/2008 | 87MBIFASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 12/11/2008 | 87JDRSTAPLE, FIXATION, BONE | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 12/11/2008 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 12/11/2008 | 87HWCSCREW, FIXATION, BONE | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 12/11/2008 | 87MAIFASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE | 118NOT LISTED | San Juan District Office (SJN-DO) |
Frequently Asked Questions
What is Ethicon Sarl, a Johnson & Johnson Company's FDA import refusal history?
Ethicon Sarl, a Johnson & Johnson Company (FEI: 3003702646) has 10 FDA import refusal record(s) in our database, spanning from 12/11/2008 to 2/19/2025.
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 Sarl, a Johnson & Johnson Company's FEI number is 3003702646.
What types of violations has Ethicon Sarl, a Johnson & Johnson Company received?
Ethicon Sarl, a Johnson & Johnson Company has been cited for 3 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 Sarl, a Johnson & Johnson Company come from?
All FDA import refusal data for Ethicon Sarl, a Johnson & Johnson Company 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.