Jml Direct America Llc
⚠️ Moderate Risk
FEI: 3010600749 • London • UNITED KINGDOM
FEI Number
3010600749
Location
London
Country
UNITED KINGDOMAddress
Regis Road, , London, , 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
NO PMA/PDP
The article appears to be a class III dev.w/o an approved applic. for premarket approval, and/or a notice of completion of product development protocol filed per section 515(b) or exempt per sect.520(g)(1).
DE/RX KIT
The article appears to be a combination medical device/prescription drug kit for which the prescription drug component was manufactured in the U.S., is offered for import by other than the manufacturer, and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
Refusal History
Frequently Asked Questions
What is Jml Direct America Llc's FDA import refusal history?
Jml Direct America Llc (FEI: 3010600749) has 2 FDA import refusal record(s) in our database, spanning from 2/5/2016 to 2/5/2016.
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. Jml Direct America Llc's FEI number is 3010600749.
What types of violations has Jml Direct America Llc received?
Jml Direct America Llc 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 Jml Direct America Llc come from?
All FDA import refusal data for Jml Direct America Llc 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.