Lenus Pharma GmbH
⚠️ Moderate Risk
FEI: 3010842687 • Vienna, Wien • AUSTRIA
FEI Number
3010842687
Location
Vienna, Wien
Country
AUSTRIAAddress
Seebockgasse 59, , Vienna, Wien, Austria
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
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/26/2017 | 54ACC90MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 11/21/2017 | 54CCH23L-CARNITINE (PROTEIN) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 11/21/2017 | 54CCH23L-CARNITINE (PROTEIN) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 12/27/2016 | 41GGY99MEDICAL FOODS, N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 7/7/2016 | 41GYT99MEDICAL FOODS, N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 7/5/2016 | 41GYT99MEDICAL FOODS, N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Lenus Pharma GmbH's FDA import refusal history?
Lenus Pharma GmbH (FEI: 3010842687) has 6 FDA import refusal record(s) in our database, spanning from 7/5/2016 to 12/26/2017.
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. Lenus Pharma GmbH's FEI number is 3010842687.
What types of violations has Lenus Pharma GmbH received?
Lenus Pharma GmbH has been cited for 1 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 Lenus Pharma GmbH come from?
All FDA import refusal data for Lenus Pharma GmbH 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.