Kirklees Medical Ltd
⚠️ Moderate Risk
FEI: 3007162411 • Brighousebrighouse • UNITED KINGDOM
FEI Number
3007162411
Location
Brighousebrighouse
Country
UNITED KINGDOMAddress
Old Farm Housekirkleesbrighouse, , Brighousebrighouse, , 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
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/18/2009 | 66VCJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Philadelphia District Office (PHI-DO) |
| 6/18/2009 | 66VCL99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Philadelphia District Office (PHI-DO) |
| 6/18/2009 | 66VCL99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Philadelphia District Office (PHI-DO) |
| 6/18/2009 | 66VCJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Philadelphia District Office (PHI-DO) |
Frequently Asked Questions
What is Kirklees Medical Ltd's FDA import refusal history?
Kirklees Medical Ltd (FEI: 3007162411) has 4 FDA import refusal record(s) in our database, spanning from 6/18/2009 to 6/18/2009.
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. Kirklees Medical Ltd's FEI number is 3007162411.
What types of violations has Kirklees Medical Ltd received?
Kirklees Medical Ltd has been cited for 1 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 Kirklees Medical Ltd come from?
All FDA import refusal data for Kirklees Medical Ltd 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.