ABBOTT DIABETES CARE LIMITED
⚠️ Moderate Risk
FEI: 3003500908 • Witney, Oxfordshire • UNITED KINGDOM
FEI Number
3003500908
Location
Witney, Oxfordshire
Country
UNITED KINGDOMAddress
Range Road, , Witney, Oxfordshire, 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).
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).
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.
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 PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
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.
NO PMA/PDP
The article appears to be a class III dev.w/o an approved applic. for premarket approval, and/or a notice of completion of product development protocol filed per section 515(b) or exempt per sect.520(g)(1).
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/29/2023 | 75LFRGLUCOSE DEHYDROGENASE, GLUCOSE | Division of Southeast Imports (DSEI) | |
| 9/9/2019 | 75LFRGLUCOSE DEHYDROGENASE, GLUCOSE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 9/9/2019 | 75LFRGLUCOSE DEHYDROGENASE, GLUCOSE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 8/23/2017 | 75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | Division of Southeast Imports (DSEI) | |
| 1/27/2017 | 75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | New Orleans District Office (NOL-DO) | |
| 9/8/2016 | 75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | 341REGISTERED | San Juan District Office (SJN-DO) |
| 9/8/2016 | 75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | 341REGISTERED | San Juan District Office (SJN-DO) |
| 9/8/2016 | 75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | 341REGISTERED | San Juan District Office (SJN-DO) |
| 11/10/2015 | 75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | Chicago District Office (CHI-DO) | |
| 8/14/2015 | 75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | 473LABELING | San Juan District Office (SJN-DO) |
| 8/19/2013 | 75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is ABBOTT DIABETES CARE LIMITED's FDA import refusal history?
ABBOTT DIABETES CARE LIMITED (FEI: 3003500908) has 11 FDA import refusal record(s) in our database, spanning from 8/19/2013 to 11/29/2023.
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. ABBOTT DIABETES CARE LIMITED's FEI number is 3003500908.
What types of violations has ABBOTT DIABETES CARE LIMITED received?
ABBOTT DIABETES CARE LIMITED has been cited for 9 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 ABBOTT DIABETES CARE LIMITED come from?
All FDA import refusal data for ABBOTT DIABETES CARE 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.