Bayer Weimar GmbH und Co. KG
⚠️ High Risk
FEI: 3002808091 • Weimar, Thuringia • GERMANY
FEI Number
3002808091
Location
Weimar, Thuringia
Country
GERMANYAddress
Dobereinerstr. 20, , Weimar, Thuringia, 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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/4/2024 | 65JIY39DROSPIRENONE | Division of Southeast Imports (DSEI) | |
| 8/16/2024 | 61BCA02CYPROTERONE ACETATE (ANTI-ANDROGEN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/4/2024 | 65JDB39DROSPIRENONE | Division of Southeast Imports (DSEI) | |
| 5/15/2024 | 65JCY24NORETHINDRONE (PROGESTIN) | Division of Northeast Imports (DNEI) | |
| 3/20/2023 | 64GBY99ESTROGEN N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/30/2021 | 65JCA31PROGESTERONE (PROGESTIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/3/2020 | 61BDB02CYPROTERONE ACETATE (ANTI-ANDROGEN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/25/2020 | 65JDA31PROGESTERONE (PROGESTIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/21/2017 | 64GDA07ESTRADIOL (ESTROGEN) | Division of Southeast Imports (DSEI) | |
| 11/9/2016 | 64GDA07ESTRADIOL (ESTROGEN) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/22/2014 | 64GDH19ETHINYL ESTRADIOL (ESTROGEN) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/7/2012 | 64GDA29LEVONORGESTREL (ESTROGEN) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 4/19/2012 | 61BDC02CYPROTERONE ACETATE (ANTI-ANDROGEN) | 75UNAPPROVED | New England District Office (NWE-DO) |
| 1/6/2011 | 64GDB07ESTRADIOL (ESTROGEN) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/16/2009 | 61BCA02CYPROTERONE ACETATE (ANTI-ANDROGEN) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 5/3/2004 | 64GDC29LEVONORGESTREL (ESTROGEN) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/2/2003 | 62OCC42METIPRANOLOL HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 342PERSONALRX | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Bayer Weimar GmbH und Co. KG's FDA import refusal history?
Bayer Weimar GmbH und Co. KG (FEI: 3002808091) has 17 FDA import refusal record(s) in our database, spanning from 10/2/2003 to 11/4/2024.
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. Bayer Weimar GmbH und Co. KG's FEI number is 3002808091.
What types of violations has Bayer Weimar GmbH und Co. KG received?
Bayer Weimar GmbH und Co. KG has been cited for 5 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 Weimar GmbH und Co. KG come from?
All FDA import refusal data for Bayer Weimar GmbH und Co. KG 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.