NATIVE ANTIGEN COMPANY
⚠️ Moderate Risk
FEI: 3013504883 • OXFORD • UNITED KINGDOM
FEI Number
3013504883
Location
OXFORD
Country
UNITED KINGDOMAddress
B LANGFORD LOCKS KIDLIN, , OXFORD, , 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.
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 |
|---|---|---|---|
| 7/21/2021 | 83QCUDENGUE VIRUS ANTIGEN ASSAY | Division of Northern Border Imports (DNBI) | |
| 7/21/2021 | 83QCUDENGUE VIRUS ANTIGEN ASSAY | Division of Northern Border Imports (DNBI) | |
| 7/21/2021 | 83QOFMULTI-TARGET RESPIRATORY SPECIMEN NUCLEIC ACID TEST INCLUDING SARS-COV-2 AND OTHER MICROBIAL AGENTS | Division of Northern Border Imports (DNBI) | |
| 7/21/2021 | 83PYSZIKA VIRUS SEROLOGICAL REAGENTS | Division of Northern Border Imports (DNBI) | |
| 7/21/2021 | 83QCUDENGUE VIRUS ANTIGEN ASSAY | Division of Northern Border Imports (DNBI) | |
| 7/21/2021 | 83OPLMULTIPLEX IMMUNOASSAY FOR MEASLES VIRUS, MUMPS VIRUS, RUBELLA AND VARICELLA ZOSTER VIRUS | Division of Northern Border Imports (DNBI) | |
| 7/21/2021 | 83QOFMULTI-TARGET RESPIRATORY SPECIMEN NUCLEIC ACID TEST INCLUDING SARS-COV-2 AND OTHER MICROBIAL AGENTS | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is NATIVE ANTIGEN COMPANY's FDA import refusal history?
NATIVE ANTIGEN COMPANY (FEI: 3013504883) has 7 FDA import refusal record(s) in our database, spanning from 7/21/2021 to 7/21/2021.
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. NATIVE ANTIGEN COMPANY's FEI number is 3013504883.
What types of violations has NATIVE ANTIGEN COMPANY received?
NATIVE ANTIGEN COMPANY has been cited for 3 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 NATIVE ANTIGEN COMPANY come from?
All FDA import refusal data for NATIVE ANTIGEN COMPANY 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.