Rocket Medical Plc
✅ Low Risk
FEI: 3002808026 • Tyne & Wear, 30028 • UNITED KINGDOM
FEI Number
3002808026
Location
Tyne & Wear, 30028
Country
UNITED KINGDOMAddress
Industrial Estate Sedling Road Wear Industrial Estate, Washington, Tyne & Wear, 3002808026, United Kingdom
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
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
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
Frequently Asked Questions
What is Rocket Medical Plc's FDA import refusal history?
Rocket Medical Plc (FEI: 3002808026) has 2 FDA import refusal record(s) in our database, spanning from 1/3/2014 to 1/10/2014.
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. Rocket Medical Plc's FEI number is 3002808026.
What types of violations has Rocket Medical Plc received?
Rocket Medical Plc 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 Rocket Medical Plc come from?
All FDA import refusal data for Rocket Medical Plc 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.