Miltenyi Biotec Gmbh
⚠️ Moderate Risk
FEI: 3004112148 • Bergisch Gladbach, North Rhine-Westphalia • GERMANY
FEI Number
3004112148
Location
Bergisch Gladbach, North Rhine-Westphalia
Country
GERMANYAddress
Friedrich-Ebert-Str. 68, , Bergisch Gladbach, North Rhine-Westphalia, 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
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/31/2024 | 73OFZBLOOD SPECIMEN COLLECTION KIT (EXCLUDES HIV TESTING) | Division of Northeast Imports (DNEI) | |
| 11/22/2022 | 57VH99IN-VITRO DIAG PRODUCTS, N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 6/29/2017 | 61CIY03REVLIMID | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is Miltenyi Biotec Gmbh's FDA import refusal history?
Miltenyi Biotec Gmbh (FEI: 3004112148) has 3 FDA import refusal record(s) in our database, spanning from 6/29/2017 to 10/31/2024.
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. Miltenyi Biotec Gmbh's FEI number is 3004112148.
What types of violations has Miltenyi Biotec Gmbh received?
Miltenyi Biotec Gmbh 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 Miltenyi Biotec Gmbh come from?
All FDA import refusal data for Miltenyi Biotec 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.