Bio-Gen Milchserum Marketing GmbH
⚠️ Moderate Risk
FEI: 3014586415 • Montabaur, Rhineland-Palatinate • GERMANY
FEI Number
3014586415
Location
Montabaur, Rhineland-Palatinate
Country
GERMANYAddress
Graf-Von-Zeppelin-Str. 2-4, , Montabaur, Rhineland-Palatinate, Germany
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
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
SUPPL GMP
The article appears to be a dietary supplement and it has been prepared, packed, or held under conditions that do not meet current good manufacturing practice regulations.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/3/2025 | 54YCL99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 3560SUPPL GMP | Division of Southeast Imports (DSEI) |
| 11/3/2025 | 54YCI99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 3560SUPPL GMP | Division of Southeast Imports (DSEI) |
| 3/31/2017 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 9/1/2015 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Bio-Gen Milchserum Marketing GmbH's FDA import refusal history?
Bio-Gen Milchserum Marketing GmbH (FEI: 3014586415) has 4 FDA import refusal record(s) in our database, spanning from 9/1/2015 to 11/3/2025.
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. Bio-Gen Milchserum Marketing GmbH's FEI number is 3014586415.
What types of violations has Bio-Gen Milchserum Marketing GmbH received?
Bio-Gen Milchserum Marketing GmbH 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 Bio-Gen Milchserum Marketing GmbH come from?
All FDA import refusal data for Bio-Gen Milchserum Marketing 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.