Bayer Diagnostics Uk Limited
⚠️ Moderate Risk
FEI: 1000380439 • Newbury, Berkshire • UNITED KINGDOM
FEI Number
1000380439
Location
Newbury, Berkshire
Country
UNITED KINGDOMAddress
N/A, , 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
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.
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 ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
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 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 |
|---|---|---|---|
| 5/20/2016 | 63NDJ04DEXPANTHENOL (CHOLINERGIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/12/2016 | 75CJGTETRABROMO-M-CRESOLSULFONPHTHALEIN, ALBUMIN | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 1/12/2016 | 75CJGTETRABROMO-M-CRESOLSULFONPHTHALEIN, ALBUMIN | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 10/23/2015 | 75CJGTETRABROMO-M-CRESOLSULFONPHTHALEIN, ALBUMIN | Detroit District Office (DET-DO) | |
| 12/23/2013 | 62FBO06CETALKONIUM CHLORIDE (ANTI-INFECTIVE, TOPICAL) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 8/28/2009 | 75JIRINDICATOR METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.) | New Orleans District Office (NOL-DO) | |
| 6/25/2007 | 78MSZSTRIP, TEST, REAGENT, RESIDUALS FOR DIALYSATE | Detroit District Office (DET-DO) | |
| 9/8/2005 | 61WAK04CLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/8/2005 | 61WAH04CLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Bayer Diagnostics Uk Limited's FDA import refusal history?
Bayer Diagnostics Uk Limited (FEI: 1000380439) has 9 FDA import refusal record(s) in our database, spanning from 9/8/2005 to 5/20/2016.
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 Uk Limited's FEI number is 1000380439.
What types of violations has Bayer Diagnostics Uk Limited received?
Bayer Diagnostics Uk Limited 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 Uk Limited come from?
All FDA import refusal data for Bayer Diagnostics Uk Limited 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.