Dunlop Systems And Components Ltd.
⚠️ Moderate Risk
FEI: 3009809440 • Coventry • UNITED KINGDOM
FEI Number
3009809440
Location
Coventry
Country
UNITED KINGDOMAddress
Holbrook Lane, , Coventry, , 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 Dunlop Systems And Components Ltd.'s FDA import refusal history?
Dunlop Systems And Components Ltd. (FEI: 3009809440) has 2 FDA import refusal record(s) in our database, spanning from 12/19/2012 to 12/19/2012.
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. Dunlop Systems And Components Ltd.'s FEI number is 3009809440.
What types of violations has Dunlop Systems And Components Ltd. received?
Dunlop Systems And Components 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 Dunlop Systems And Components Ltd. come from?
All FDA import refusal data for Dunlop Systems And Components 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.