Tricomed Surgical Limited
⚠️ Moderate Risk
FEI: 3010715506 • Addiscombe • UNITED KINGDOM
FEI Number
3010715506
Location
Addiscombe
Country
UNITED KINGDOMAddress
10 Tenterden Rd, , Addiscombe, , 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/9/2014 | 78FBMCANNULA AND TROCAR, SUPRAPUBIC, NON-DISPOSABLE | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 5/9/2014 | 78KOASURGICAL INSTRUMENTS, G-U, MANUAL (AND ACCESSORIES) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 5/9/2014 | 78KOASURGICAL INSTRUMENTS, G-U, MANUAL (AND ACCESSORIES) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Tricomed Surgical Limited's FDA import refusal history?
Tricomed Surgical Limited (FEI: 3010715506) has 3 FDA import refusal record(s) in our database, spanning from 5/9/2014 to 5/9/2014.
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. Tricomed Surgical Limited's FEI number is 3010715506.
What types of violations has Tricomed Surgical Limited received?
Tricomed Surgical 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 Tricomed Surgical Limited come from?
All FDA import refusal data for Tricomed Surgical 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.