B. Braun Melsungen AG
⚠️ High Risk
FEI: 3002806469 • Melsungen, Hassia • GERMANY
FEI Number
3002806469
Location
Melsungen, Hassia
Country
GERMANYAddress
Carl-Braun-Str. 1, , Melsungen, Hassia, Germany
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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).
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).
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.
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.
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/11/2025 | 58OIP99MONOCLONAL ANTIBODY, NEC | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 5/28/2025 | 80KZHINTRODUCER, SYRINGE NEEDLE | Division of Southeast Imports (DSEI) | |
| 6/20/2023 | 80DQFACTUATOR, SYRINGE, INJECTOR TYPE | Division of Northeast Imports (DNEI) | |
| 6/20/2023 | 80DQFACTUATOR, SYRINGE, INJECTOR TYPE | Division of Northeast Imports (DNEI) | |
| 6/20/2023 | 80ORCAIR FILTER PORTABLE APPARATUS | Division of Northeast Imports (DNEI) | |
| 5/30/2023 | 88NNKCONTAINER, SPECIMEN MAILER AND STORAGE, NON-STERILE | Division of Southeast Imports (DSEI) | |
| 11/20/2020 | 88KJHAPPARATUS, PERFUSION | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 11/20/2020 | 88KJHAPPARATUS, PERFUSION | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 4/20/2018 | 74MALGRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE | Division of Southeast Imports (DSEI) | |
| 4/29/2016 | 80FRNPUMP, INFUSION | Cincinnati District Office (CIN-DO) | |
| 1/30/2015 | 80FRNPUMP, INFUSION | 341REGISTERED | Florida District Office (FLA-DO) |
| 10/2/2013 | 74DQIPUMP, WITHDRAWAL/INFUSION | New Orleans District Office (NOL-DO) | |
| 9/17/2013 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 6/18/2012 | 64XAL06SALICYLIC ACID (KERATOLYTIC) | New Orleans District Office (NOL-DO) | |
| 6/22/2009 | 79JCYCATHETER, INFUSION | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 8/12/2005 | 80FRNPUMP, INFUSION | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is B. Braun Melsungen AG's FDA import refusal history?
B. Braun Melsungen AG (FEI: 3002806469) has 16 FDA import refusal record(s) in our database, spanning from 8/12/2005 to 12/11/2025.
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. B. Braun Melsungen AG's FEI number is 3002806469.
What types of violations has B. Braun Melsungen AG received?
B. Braun Melsungen AG has been cited for 6 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 B. Braun Melsungen AG come from?
All FDA import refusal data for B. Braun Melsungen AG 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.