OXFORD MEDICAL INSTRUMENTS LTD.
⚠️ Moderate Risk
FEI: 3012489208 • SURREY • UNITED KINGDOM
FEI Number
3012489208
Location
SURREY
Country
UNITED KINGDOMAddress
CURZON HOUSE 2ND FLOOR, , SURREY, , 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
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.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
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 |
|---|---|---|---|
| 11/15/2024 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Division of Southeast Imports (DSEI) | |
| 7/9/2021 | 77KCOINHALER, NASAL | Division of Northern Border Imports (DNBI) | |
| 7/9/2021 | 77KCOINHALER, NASAL | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is OXFORD MEDICAL INSTRUMENTS LTD.'s FDA import refusal history?
OXFORD MEDICAL INSTRUMENTS LTD. (FEI: 3012489208) has 3 FDA import refusal record(s) in our database, spanning from 7/9/2021 to 11/15/2024.
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. OXFORD MEDICAL INSTRUMENTS LTD.'s FEI number is 3012489208.
What types of violations has OXFORD MEDICAL INSTRUMENTS LTD. received?
OXFORD MEDICAL INSTRUMENTS LTD. 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 OXFORD MEDICAL INSTRUMENTS LTD. come from?
All FDA import refusal data for OXFORD MEDICAL INSTRUMENTS 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.