Abbott GmbH
⚠️ Moderate Risk
FEI: 3002809144 • Wiesbaden, Hassia • GERMANY
FEI Number
3002809144
Location
Wiesbaden, Hassia
Country
GERMANYAddress
Max-Planck Ring 2, , Wiesbaden, Hassia, 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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/4/2024 | 75PYVHOSPITAL CONTINUOUS GLUCOSE MONITORING SYSTEM | Division of Southeast Imports (DSEI) | |
| 2/8/2022 | 88PPMGENERAL PURPOSE REAGENT | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 3/4/2011 | 79GAANEEDLE, ASPIRATION AND INJECTION, DISPOSABLE | 118NOT LISTED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Abbott GmbH's FDA import refusal history?
Abbott GmbH (FEI: 3002809144) has 3 FDA import refusal record(s) in our database, spanning from 3/4/2011 to 1/4/2024.
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. Abbott GmbH's FEI number is 3002809144.
What types of violations has Abbott GmbH received?
Abbott GmbH has been cited for 2 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 Abbott GmbH come from?
All FDA import refusal data for Abbott 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.