Alber GmbH
⚠️ High Risk
FEI: 3004730072 • Albstadt, Baden-Wurttemberg • GERMANY
FEI Number
3004730072
Location
Albstadt, Baden-Wurttemberg
Country
GERMANYAddress
Vor Dem Weisen Stein 14, , Albstadt, 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
DEVICEGMPS
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.
DE IMP GMP
The article is subject to refusal of admission pursuant to section 801(a)(1) in that it appears that the methods used in, or the facilities or controls used for, the manufacture of the device do not conform to the applicable requirements of section 520(f).
DEVGMPS
The article appears to be a device for which the methods, facilities, or controls used in, or the facilities or controls used for, its manufacture, packing, storage or installation do not conform to the requirements of Sec. 520(f) and any applicable variance under Sec. 520(f)(2).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/9/2018 | 89ITIWHEELCHAIR, POWERED | 3724DEVGMPS | Division of Southeast Imports (DSEI) |
| 1/9/2018 | 89ITIWHEELCHAIR, POWERED | 3724DEVGMPS | Division of Southeast Imports (DSEI) |
| 1/9/2018 | 89ITIWHEELCHAIR, POWERED | 3724DEVGMPS | Division of Southeast Imports (DSEI) |
| 1/9/2018 | 89ITIWHEELCHAIR, POWERED | 3724DEVGMPS | Division of Southeast Imports (DSEI) |
| 1/9/2018 | 89ITIWHEELCHAIR, POWERED | 3724DEVGMPS | Division of Southeast Imports (DSEI) |
| 1/9/2018 | 89ITIWHEELCHAIR, POWERED | 3724DEVGMPS | Division of Southeast Imports (DSEI) |
| 1/9/2018 | 89ITIWHEELCHAIR, POWERED | 3724DEVGMPS | Division of Southeast Imports (DSEI) |
| 12/22/2017 | 89ITIWHEELCHAIR, POWERED | 290DE IMP GMP | Division of Southeast Imports (DSEI) |
| 12/22/2017 | 89ITIWHEELCHAIR, POWERED | 290DE IMP GMP | Division of Southeast Imports (DSEI) |
| 12/22/2017 | 89ITIWHEELCHAIR, POWERED | 290DE IMP GMP | Division of Southeast Imports (DSEI) |
| 12/22/2017 | 89ITIWHEELCHAIR, POWERED | 290DE IMP GMP | Division of Southeast Imports (DSEI) |
| 12/18/2017 | 89ITIWHEELCHAIR, POWERED | 2780DEVICEGMPS | Division of Southeast Imports (DSEI) |
| 12/7/2017 | 89ITIWHEELCHAIR, POWERED | 2780DEVICEGMPS | Division of Northern Border Imports (DNBI) |
| 12/7/2017 | 89ITIWHEELCHAIR, POWERED | 2780DEVICEGMPS | Division of Northern Border Imports (DNBI) |
| 12/7/2017 | 89ITIWHEELCHAIR, POWERED | 2780DEVICEGMPS | Division of Northern Border Imports (DNBI) |
| 12/7/2017 | 89ITIWHEELCHAIR, POWERED | 2780DEVICEGMPS | Division of Northern Border Imports (DNBI) |
| 12/7/2017 | 89ITIWHEELCHAIR, POWERED | 2780DEVICEGMPS | Division of Northern Border Imports (DNBI) |
| 12/7/2017 | 89ITIWHEELCHAIR, POWERED | 2780DEVICEGMPS | Division of Northern Border Imports (DNBI) |
| 12/7/2017 | 89ITIWHEELCHAIR, POWERED | 2780DEVICEGMPS | Division of Northern Border Imports (DNBI) |
| 12/7/2017 | 89ITIWHEELCHAIR, POWERED | 2780DEVICEGMPS | Division of Northern Border Imports (DNBI) |
| 12/7/2017 | 89ITIWHEELCHAIR, POWERED | 2780DEVICEGMPS | Division of Northern Border Imports (DNBI) |
| 12/4/2017 | 89ITIWHEELCHAIR, POWERED | 290DE IMP GMP | Division of Southeast Imports (DSEI) |
| 12/1/2017 | 89ITIWHEELCHAIR, POWERED | 2780DEVICEGMPS | Division of Southeast Imports (DSEI) |
| 12/1/2017 | 89ITIWHEELCHAIR, POWERED | 2780DEVICEGMPS | Division of Southeast Imports (DSEI) |
| 12/1/2017 | 89ITIWHEELCHAIR, POWERED | 2780DEVICEGMPS | Division of Southeast Imports (DSEI) |
| 12/1/2017 | 89ITIWHEELCHAIR, POWERED | 290DE IMP GMP | Division of Southeast Imports (DSEI) |
| 11/20/2017 | 89ITIWHEELCHAIR, POWERED | 290DE IMP GMP | Division of Southeast Imports (DSEI) |
| 11/20/2017 | 89ITIWHEELCHAIR, POWERED | 290DE IMP GMP | Division of Southeast Imports (DSEI) |
| 11/20/2017 | 89ITIWHEELCHAIR, POWERED | 290DE IMP GMP | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Alber GmbH's FDA import refusal history?
Alber GmbH (FEI: 3004730072) has 29 FDA import refusal record(s) in our database, spanning from 11/20/2017 to 1/9/2018.
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. Alber GmbH's FEI number is 3004730072.
What types of violations has Alber GmbH received?
Alber 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 Alber GmbH come from?
All FDA import refusal data for Alber 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.