Biotech Industry
⚠️ Moderate Risk
FEI: 3003165206 • Luxemburg • LUXEMBOURG
FEI Number
3003165206
Location
Luxemburg
Country
LUXEMBOURGAddress
212 Rue Bernard Haal, , Luxemburg, , Luxembourg
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
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
NO LICENSE
The article is subject to refusal of admission under section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because it appears to be a biological product for which a biologics license is not in effect under the Public Health Service Act, Part F, Subpart 1-Biological Products, Section 351(a), and it is not the subject of an Investigational New Drug application that is in effect. Therefore, it appears to be a new drug under 201(p) of the FD&C Act that it is in violation of section 505(a) of the FD&C Act because it lacks a new drug approval and because it is misbranded under section 502(f)(1)of the FD&C Act because it fails to bear adequate directions for use
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/13/2002 | 80LDQDEVICE, GENERAL MEDICAL | 237NO PMA | New Orleans District Office (NOL-DO) |
| 6/13/2002 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 71NO LICENSE | New Orleans District Office (NOL-DO) |
| 5/9/2002 | 80LDQDEVICE, GENERAL MEDICAL | 508NO 510(K) | New Orleans District Office (NOL-DO) |
| 3/25/2002 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 237NO PMA | New York District Office (NYK-DO) |
| 3/20/2002 | 79MDMINSTRUMENT, MANUAL, GENERAL SURGICAL | 237NO PMA | New Orleans District Office (NOL-DO) |
| 3/20/2002 | 79MDMINSTRUMENT, MANUAL, GENERAL SURGICAL | 237NO PMA | New Orleans District Office (NOL-DO) |
| 10/16/2001 | 80LDQDEVICE, GENERAL MEDICAL | 237NO PMA | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Biotech Industry's FDA import refusal history?
Biotech Industry (FEI: 3003165206) has 7 FDA import refusal record(s) in our database, spanning from 10/16/2001 to 6/13/2002.
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. Biotech Industry's FEI number is 3003165206.
What types of violations has Biotech Industry received?
Biotech Industry 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 Biotech Industry come from?
All FDA import refusal data for Biotech Industry 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.