Laboratorie Leo
⚠️ Moderate Risk
FEI: 3009440403 • Voisins Le Bretonneux, Yvelines • FRANCE
FEI Number
3009440403
Location
Voisins Le Bretonneux, Yvelines
Country
FRANCEAddress
2 Rue Rene Caudron, , Voisins Le Bretonneux, Yvelines, France
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
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
RX LEGEND
The article appears to be a prescription drug without a prescription drug legend as required by Section 503(b)(4).
Refusal History
Frequently Asked Questions
What is Laboratorie Leo's FDA import refusal history?
Laboratorie Leo (FEI: 3009440403) has 1 FDA import refusal record(s) in our database, spanning from 9/21/2012 to 9/21/2012.
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. Laboratorie Leo's FEI number is 3009440403.
What types of violations has Laboratorie Leo received?
Laboratorie Leo has been cited for 3 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 Laboratorie Leo come from?
All FDA import refusal data for Laboratorie Leo 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.