Roche Diabetes Care GmbH
⚠️ High Risk
FEI: 3011806823 • Mannheim, Baden-Wurttemberg • GERMANY
FEI Number
3011806823
Location
Mannheim, Baden-Wurttemberg
Country
GERMANYAddress
Sandhofer Str. 116, , Mannheim, Baden-Wurttemberg, 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).
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.
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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 PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
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 |
|---|---|---|---|
| 4/28/2025 | 75JJXSINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED) | Division of Southeast Imports (DSEI) | |
| 5/19/2024 | 75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | Division of Southeast Imports (DSEI) | |
| 3/28/2024 | 75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | Division of Southeast Imports (DSEI) | |
| 3/27/2024 | 75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | Division of Southeast Imports (DSEI) | |
| 2/15/2024 | 75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | Division of Southeast Imports (DSEI) | |
| 9/22/2023 | 75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | Division of Southeast Imports (DSEI) | |
| 10/19/2022 | 79FMKSINGLE USE ONLY BLOOD LANCET WITH AN INTEGRAL SHARPS INJURY PREVENTION FEATURE | Division of Southeast Imports (DSEI) | |
| 11/4/2021 | 79FMKSINGLE USE ONLY BLOOD LANCET WITH AN INTEGRAL SHARPS INJURY PREVENTION FEATURE | Division of Southeast Imports (DSEI) | |
| 11/23/2018 | 75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | 16DIRECTIONS | Division of Southeast Imports (DSEI) |
| 11/16/2018 | 79FMKSINGLE USE ONLY BLOOD LANCET WITH AN INTEGRAL SHARPS INJURY PREVENTION FEATURE | Division of Southeast Imports (DSEI) | |
| 11/16/2018 | 75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | Division of Southeast Imports (DSEI) | |
| 11/16/2018 | 79FMKSINGLE USE ONLY BLOOD LANCET WITH AN INTEGRAL SHARPS INJURY PREVENTION FEATURE | Division of Southeast Imports (DSEI) | |
| 11/14/2018 | 75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | Division of Southeast Imports (DSEI) | |
| 10/27/2017 | 75JJXSINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Roche Diabetes Care GmbH's FDA import refusal history?
Roche Diabetes Care GmbH (FEI: 3011806823) has 14 FDA import refusal record(s) in our database, spanning from 10/27/2017 to 4/28/2025.
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. Roche Diabetes Care GmbH's FEI number is 3011806823.
What types of violations has Roche Diabetes Care GmbH received?
Roche Diabetes Care GmbH has been cited for 10 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 Roche Diabetes Care GmbH come from?
All FDA import refusal data for Roche Diabetes Care 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.