Bayer Diagnostics
⚠️ Moderate Risk
FEI: 3001670079 • Newbury, Berkshire • UNITED KINGDOM
FEI Number
3001670079
Location
Newbury, Berkshire
Country
UNITED KINGDOMAddress
Bayer House, Strawberry Hill, Newbury, Berkshire, United Kingdom
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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).
COL ADDED
The article appears to bear or contain, for the purpose of coloring only, a color additive which is unsafe within the meaning of Section 721(a).
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
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.
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/18/2023 | 55QP45PHENOL (PHARMACEUTIC NECESSITY - PRESERVATIVE) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 7/16/2014 | 75CJGTETRABROMO-M-CRESOLSULFONPHTHALEIN, ALBUMIN | Cincinnati District Office (CIN-DO) | |
| 10/11/2013 | 56OJP05ENROFLOXACIN (FLUOROQUINOLONE) | 72NEW VET DR | Cincinnati District Office (CIN-DO) |
| 6/8/2011 | 61WCE45FLUCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/1/2011 | 64GCY29LEVONORGESTREL (ESTROGEN) | 179AGR RX | Cincinnati District Office (CIN-DO) |
| 3/18/2011 | 85HDTDEVICE, INTRAUTERINE, CONTRACEPTIVE AND INTRODUCER | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 10/5/2010 | 61BDA02CYPROTERONE ACETATE (ANTI-ANDROGEN) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/15/2009 | 62VCJ18ACYCLOVIR (ANTI-VIRAL) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 6/9/2008 | 61BDY02CYPROTERONE ACETATE (ANTI-ANDROGEN) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/15/2004 | 54YGJ99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 2/11/2003 | 66VBO99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) | |
| 11/14/2001 | 61NDA99ANTI-DEPRESSANT N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 11/7/2001 | 61FBY54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Bayer Diagnostics's FDA import refusal history?
Bayer Diagnostics (FEI: 3001670079) has 13 FDA import refusal record(s) in our database, spanning from 11/7/2001 to 5/18/2023.
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 Diagnostics's FEI number is 3001670079.
What types of violations has Bayer Diagnostics received?
Bayer Diagnostics has been cited for 6 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 Diagnostics come from?
All FDA import refusal data for Bayer Diagnostics 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.