Bayer Bitterfeld GmbH
⚠️ High Risk
FEI: 3003882513 • Bitterfeld-Wolfen, Saxony-Anhalt • GERMANY
FEI Number
3003882513
Location
Bitterfeld-Wolfen, Saxony-Anhalt
Country
GERMANYAddress
Salegaster Chaussee 1, , Bitterfeld-Wolfen, Saxony-Anhalt, 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
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).
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.
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/25/2025 | 62GAY50NAPROXEN SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/24/2023 | 62GBA50NAPROXEN SODIUM (ANTI-INFLAMMATORY) | Division of Northeast Imports (DNEI) | |
| 7/26/2022 | 62GDY49NAPROXEN (ANTI-INFLAMMATORY) | Division of Southeast Imports (DSEI) | |
| 5/14/2020 | 60LDY05ASPIRIN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/6/2020 | 62GDA50NAPROXEN SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Bayer Bitterfeld GmbH's FDA import refusal history?
Bayer Bitterfeld GmbH (FEI: 3003882513) has 5 FDA import refusal record(s) in our database, spanning from 3/6/2020 to 6/25/2025.
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. Bayer Bitterfeld GmbH's FEI number is 3003882513.
What types of violations has Bayer Bitterfeld GmbH received?
Bayer Bitterfeld GmbH has been cited for 4 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 Bayer Bitterfeld GmbH come from?
All FDA import refusal data for Bayer Bitterfeld 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.