Braun GmbH
⚠️ Moderate Risk
FEI: 1000227535 • Kronberg Im Taunus, Hesse • GERMANY
FEI Number
1000227535
Location
Kronberg Im Taunus, Hesse
Country
GERMANYAddress
Frankfurter Str. 145, , Kronberg Im Taunus, Hesse, 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).
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 ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
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 |
|---|---|---|---|
| 1/12/2024 | 76JEQTOOTHBRUSH, POWERED | Division of Northern Border Imports (DNBI) | |
| 7/11/2023 | 76EFWTOOTHBRUSH, MANUAL | Division of Southeast Imports (DSEI) | |
| 3/12/2022 | 76JEQTOOTHBRUSH, POWERED | Division of Southeast Imports (DSEI) | |
| 1/24/2022 | 76JEQTOOTHBRUSH, POWERED | Division of Southeast Imports (DSEI) | |
| 1/24/2022 | 76JEQTOOTHBRUSH, POWERED | Division of Southeast Imports (DSEI) | |
| 8/29/2002 | 76JEQTOOTHBRUSH, POWERED | 118NOT LISTED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Braun GmbH's FDA import refusal history?
Braun GmbH (FEI: 1000227535) has 6 FDA import refusal record(s) in our database, spanning from 8/29/2002 to 1/12/2024.
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. Braun GmbH's FEI number is 1000227535.
What types of violations has Braun GmbH received?
Braun GmbH has been cited for 4 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 Braun GmbH come from?
All FDA import refusal data for Braun 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.