Takeda GmbH, Plant Oranienburg
⚠️ High Risk
FEI: 3002807809 • Oranienburg, Brandenburg • GERMANY
FEI Number
3002807809
Location
Oranienburg, Brandenburg
Country
GERMANYAddress
Lehnitzstr. 70-98, , Oranienburg, Brandenburg, 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).
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 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 |
|---|---|---|---|
| 9/3/2025 | 63SCC99DENTAL PROTECTANT N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 10/7/2022 | 62TCY07PANTOPRAZOLE SODIUM | Division of Southeast Imports (DSEI) | |
| 2/1/2022 | 62OCC18BISOPROLOL FUMARATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/12/2020 | 62VDA77EMTRICITABINE; TENOFOVIR DISOPROXIL FUMERATE (ANTI-VIRAL) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/17/2007 | 90KTAMEDIUM, CONTRAST, RADIOLOGIC | 508NO 510(K) | New Orleans District Office (NOL-DO) |
| 10/17/2007 | 90KTAMEDIUM, CONTRAST, RADIOLOGIC | 508NO 510(K) | New Orleans District Office (NOL-DO) |
| 1/9/2007 | 61EIQ99ANTI-ASTHMATIC, N.E.C. | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 1/9/2007 | 61EIQ99ANTI-ASTHMATIC, N.E.C. | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Takeda GmbH, Plant Oranienburg's FDA import refusal history?
Takeda GmbH, Plant Oranienburg (FEI: 3002807809) has 8 FDA import refusal record(s) in our database, spanning from 1/9/2007 to 9/3/2025.
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. Takeda GmbH, Plant Oranienburg's FEI number is 3002807809.
What types of violations has Takeda GmbH, Plant Oranienburg received?
Takeda GmbH, Plant Oranienburg 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 Takeda GmbH, Plant Oranienburg come from?
All FDA import refusal data for Takeda GmbH, Plant Oranienburg 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.