YORKTEST LABORATORIES LIMITED
⚠️ Moderate Risk
FEI: 3003438526 • York, YOR • UNITED KINGDOM
FEI Number
3003438526
Location
York, YOR
Country
UNITED KINGDOMAddress
Triune Court, Monks Cross Drive, York, YOR, 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
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.
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 |
|---|---|---|---|
| 5/9/2025 | 79FMKSINGLE USE ONLY BLOOD LANCET WITH AN INTEGRAL SHARPS INJURY PREVENTION FEATURE | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 5/9/2025 | 79FMKSINGLE USE ONLY BLOOD LANCET WITH AN INTEGRAL SHARPS INJURY PREVENTION FEATURE | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 3/6/2019 | 75JKATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | Division of Southeast Imports (DSEI) | |
| 7/7/2006 | 73CBTKIT, SAMPLING, ARTERIAL BLOOD | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is YORKTEST LABORATORIES LIMITED's FDA import refusal history?
YORKTEST LABORATORIES LIMITED (FEI: 3003438526) has 4 FDA import refusal record(s) in our database, spanning from 7/7/2006 to 5/9/2025.
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. YORKTEST LABORATORIES LIMITED's FEI number is 3003438526.
What types of violations has YORKTEST LABORATORIES LIMITED received?
YORKTEST LABORATORIES LIMITED has been cited for 2 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 YORKTEST LABORATORIES LIMITED come from?
All FDA import refusal data for YORKTEST LABORATORIES 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.