Surgical Specialties Corporation Limited (UK)
⚠️ Moderate Risk
FEI: 3007109793 • Taunton, Somerset • UNITED KINGDOM
FEI Number
3007109793
Location
Taunton, Somerset
Country
UNITED KINGDOMAddress
Tancred Street, , Taunton, Somerset, 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
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
Refusal History
Frequently Asked Questions
What is Surgical Specialties Corporation Limited (UK)'s FDA import refusal history?
Surgical Specialties Corporation Limited (UK) (FEI: 3007109793) has 2 FDA import refusal record(s) in our database, spanning from 12/10/2007 to 12/10/2007.
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. Surgical Specialties Corporation Limited (UK)'s FEI number is 3007109793.
What types of violations has Surgical Specialties Corporation Limited (UK) received?
Surgical Specialties Corporation Limited (UK) 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 Surgical Specialties Corporation Limited (UK) come from?
All FDA import refusal data for Surgical Specialties Corporation Limited (UK) 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.