DEPUY SYNTHES IRELAND LIMITED
⚠️ Moderate Risk
FEI: 3015937493 • Cork, Co. CORK • IRELAND
FEI Number
3015937493
Location
Cork, Co. CORK
Country
IRELANDAddress
West Wind, 21 South Lodge, Cork, Co. CORK, Ireland
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/7/2024 | 87JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER | 3280FRNMFGREG | Division of Southwest Imports (DSWI) |
Frequently Asked Questions
What is DEPUY SYNTHES IRELAND LIMITED's FDA import refusal history?
DEPUY SYNTHES IRELAND LIMITED (FEI: 3015937493) has 1 FDA import refusal record(s) in our database, spanning from 6/7/2024 to 6/7/2024.
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. DEPUY SYNTHES IRELAND LIMITED's FEI number is 3015937493.
What types of violations has DEPUY SYNTHES IRELAND LIMITED received?
DEPUY SYNTHES IRELAND LIMITED 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 DEPUY SYNTHES IRELAND LIMITED come from?
All FDA import refusal data for DEPUY SYNTHES IRELAND LIMITED 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.