Ledrop Exports Limited
⚠️ Moderate Risk
FEI: 3001185546 • London, KEC • UNITED KINGDOM
FEI Number
3001185546
Location
London, KEC
Country
UNITED KINGDOMAddress
251 Brompton Road, , London, KEC, 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
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).
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 Ledrop Exports Limited's FDA import refusal history?
Ledrop Exports Limited (FEI: 3001185546) has 2 FDA import refusal record(s) in our database, spanning from 1/29/2002 to 1/5/2006.
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. Ledrop Exports Limited's FEI number is 3001185546.
What types of violations has Ledrop Exports Limited received?
Ledrop Exports Limited 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 Ledrop Exports Limited come from?
All FDA import refusal data for Ledrop Exports Limited 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.