Depuy International Ltd.
⚠️ Moderate Risk
FEI: 1000199976 • Leeds • UNITED KINGDOM
FEI Number
1000199976
Location
Leeds
Country
UNITED KINGDOMAddress
St. Anthonys Road, , Leeds, , United Kingdom
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).
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 |
|---|---|---|---|
| 5/4/2015 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 11/17/2014 | 87LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED | 341REGISTERED | Division of Northern Border Imports (DNBI) |
| 11/17/2014 | 87KRSPROSTHESIS, KNEE, HEMI-, TIBIAL RESURFACING (UNCEMENTED) | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is Depuy International Ltd.'s FDA import refusal history?
Depuy International Ltd. (FEI: 1000199976) has 3 FDA import refusal record(s) in our database, spanning from 11/17/2014 to 5/4/2015.
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 International Ltd.'s FEI number is 1000199976.
What types of violations has Depuy International Ltd. received?
Depuy International Ltd. has been cited for 2 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 International Ltd. come from?
All FDA import refusal data for Depuy International Ltd. 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.