Braun Medical S.A.
✅ Low Risk
FEI: 1000623913 • Boulogne Billancourt, Hauts de Seine • FRANCE
FEI Number
1000623913
Location
Boulogne Billancourt, Hauts de Seine
Country
FRANCEAddress
204 Avenue Du Marechal Juin, , Boulogne Billancourt, Hauts de Seine, France
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
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
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
Frequently Asked Questions
What is Braun Medical S.A.'s FDA import refusal history?
Braun Medical S.A. (FEI: 1000623913) has 1 FDA import refusal record(s) in our database, spanning from 9/1/2006 to 9/1/2006.
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. Braun Medical S.A.'s FEI number is 1000623913.
What types of violations has Braun Medical S.A. received?
Braun Medical S.A. 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 Braun Medical S.A. come from?
All FDA import refusal data for Braun Medical S.A. 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.