Fab Medical Ltd
⚠️ Moderate Risk
FEI: 3006992513 • Hampshire • UNITED KINGDOM
FEI Number
3006992513
Location
Hampshire
Country
UNITED KINGDOMAddress
Unit 38 Romsey Industrial Estate, , Hampshire, , 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
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Refusal History
Frequently Asked Questions
What is Fab Medical Ltd's FDA import refusal history?
Fab Medical Ltd (FEI: 3006992513) has 2 FDA import refusal record(s) in our database, spanning from 10/23/2009 to 10/23/2009.
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. Fab Medical Ltd's FEI number is 3006992513.
What types of violations has Fab Medical Ltd received?
Fab Medical Ltd 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 Fab Medical Ltd come from?
All FDA import refusal data for Fab Medical 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.