Downs Surgical
⚠️ Moderate Risk
FEI: 3002751896 • Sheffield • UNITED KINGDOM
FEI Number
3002751896
Location
Sheffield
Country
UNITED KINGDOMAddress
Thornecliff Park, , Sheffield, , 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
Frequently Asked Questions
What is Downs Surgical's FDA import refusal history?
Downs Surgical (FEI: 3002751896) has 2 FDA import refusal record(s) in our database, spanning from 7/26/2004 to 8/20/2012.
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. Downs Surgical's FEI number is 3002751896.
What types of violations has Downs Surgical received?
Downs Surgical 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 Downs Surgical come from?
All FDA import refusal data for Downs Surgical 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.