Abbott Laboratories GmbH
⚠️ High Risk
FEI: 3002808216 • Neustadt am Rubenberge, Lower Saxony • GERMANY
FEI Number
3002808216
Location
Neustadt am Rubenberge, Lower Saxony
Country
GERMANYAddress
Justus-von-Liebig-Str. 33, , Neustadt am Rubenberge, Lower Saxony, 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
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.
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).
Refusal History
Frequently Asked Questions
What is Abbott Laboratories GmbH's FDA import refusal history?
Abbott Laboratories GmbH (FEI: 3002808216) has 2 FDA import refusal record(s) in our database, spanning from 5/22/2024 to 8/1/2025.
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. Abbott Laboratories GmbH's FEI number is 3002808216.
What types of violations has Abbott Laboratories GmbH received?
Abbott Laboratories 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 Laboratories GmbH come from?
All FDA import refusal data for Abbott Laboratories 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.