ETHICON ENDO-SURGERY
⚠️ Moderate Risk
FEI: 3014560487 • Chilhuahua • MEXICO
FEI Number
3014560487
Location
Chilhuahua
Country
MEXICOAddress
Avenida De Las Torres N, , Chilhuahua, , 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
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).
Refusal History
Frequently Asked Questions
What is ETHICON ENDO-SURGERY's FDA import refusal history?
ETHICON ENDO-SURGERY (FEI: 3014560487) has 3 FDA import refusal record(s) in our database, spanning from 3/1/2021 to 3/1/2021.
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 FEI number is 3014560487.
What types of violations has ETHICON ENDO-SURGERY received?
ETHICON ENDO-SURGERY 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 come from?
All FDA import refusal data for ETHICON 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.