Q-Med S.A.R.L.
⚠️ Moderate Risk
FEI: 3003614417 • Paris, Paris • FRANCE
FEI Number
3003614417
Location
Paris, Paris
Country
FRANCEAddress
49 Rue De Lisbonne, , Paris, Paris, 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.
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 Q-Med S.A.R.L.'s FDA import refusal history?
Q-Med S.A.R.L. (FEI: 3003614417) has 2 FDA import refusal record(s) in our database, spanning from 4/16/2002 to 4/1/2004.
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. Q-Med S.A.R.L.'s FEI number is 3003614417.
What types of violations has Q-Med S.A.R.L. received?
Q-Med S.A.R.L. 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 Q-Med S.A.R.L. come from?
All FDA import refusal data for Q-Med S.A.R.L. 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.