Moor Instruments Ltd
⚠️ Moderate Risk
FEI: 1000279065 • Axminster, Devon • UNITED KINGDOM
FEI Number
1000279065
Location
Axminster, Devon
Country
UNITED KINGDOMAddress
Millwey Rise Industrial Estate, , Axminster, Devon, 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
DE IMP GMP
The article is subject to refusal of admission pursuant to section 801(a)(1) in that it appears that the methods used in, or the facilities or controls used for, the manufacture of the device do not conform to the applicable requirements of section 520(f).
DEVGMPS
The article appears to be a device for which the methods, facilities, or controls used in, or the facilities or controls used for, its manufacture, packing, storage or installation do not conform to the requirements of Sec. 520(f) and any applicable variance under Sec. 520(f)(2).
Refusal History
Frequently Asked Questions
What is Moor Instruments Ltd's FDA import refusal history?
Moor Instruments Ltd (FEI: 1000279065) has 2 FDA import refusal record(s) in our database, spanning from 6/3/2015 to 6/3/2015.
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. Moor Instruments Ltd's FEI number is 1000279065.
What types of violations has Moor Instruments Ltd received?
Moor Instruments Ltd has been cited for 2 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 Moor Instruments Ltd come from?
All FDA import refusal data for Moor Instruments 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.