Bayer AG
⚠️ High Risk
FEI: 3002808084 • Bergkamen, North Rhine-Westphalia • GERMANY
FEI Number
3002808084
Location
Bergkamen, North Rhine-Westphalia
Country
GERMANYAddress
Ernst-Schering-Str. 14, , Bergkamen, North Rhine-Westphalia, 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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
NON STD
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/21/2023 | 60DDA99ADRENOCORTICAL STEROID N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/22/2019 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/6/2007 | 64RCP99HORMONE N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/20/2007 | 65JCS99PROGESTIN N.E.C. | New York District Office (NYK-DO) | |
| 1/3/2007 | 65JCS21MEDROXYPROGESTERONE ACETATE (PROGESTIN) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 9/13/2006 | 65LCP99PROTECTANT N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/13/2006 | 65JCP39DROSPIRENONE | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/26/2006 | 65JCP99PROGESTIN N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/2/2005 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 11/22/2004 | 64GDC07ESTRADIOL (ESTROGEN) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/13/2004 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/19/2004 | 65JCS21MEDROXYPROGESTERONE ACETATE (PROGESTIN) | 118NOT LISTED | New York District Office (NYK-DO) |
| 6/25/2002 | 90KTAMEDIUM, CONTRAST, RADIOLOGIC | 47NON STD | Minneapolis District Office (MIN-DO) |
Frequently Asked Questions
What is Bayer AG's FDA import refusal history?
Bayer AG (FEI: 3002808084) has 13 FDA import refusal record(s) in our database, spanning from 6/25/2002 to 3/21/2023.
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 AG's FEI number is 3002808084.
What types of violations has Bayer AG received?
Bayer AG 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 AG come from?
All FDA import refusal data for Bayer AG 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.