LifeScan Scotland LTD.
⚠️ Moderate Risk
FEI: 3001058982 • Inverness • UNITED KINGDOM
FEI Number
3001058982
Location
Inverness
Country
UNITED KINGDOMAddress
Beechwood Park North, , Inverness, , 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
DEVICEGMPS
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.
DE IMP GMP
The article is subject to refusal of admission pursuant to section 801(a)(1) in that it appears that the methods used in, or the facilities or controls used for, the manufacture of the device do not conform to the applicable requirements of section 520(f).
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).
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
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).
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 |
|---|---|---|---|
| 2/2/2012 | 75CGAGLUCOSE OXIDASE, GLUCOSE | Detroit District Office (DET-DO) | |
| 12/1/2011 | 75CGAGLUCOSE OXIDASE, GLUCOSE | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 10/18/2011 | 75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | New York District Office (NYK-DO) | |
| 8/19/2011 | 75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | 237NO PMA | New York District Office (NYK-DO) |
| 7/22/2011 | 75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | 290DE IMP GMP | Detroit District Office (DET-DO) |
| 12/24/2009 | 75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | 341REGISTERED | New York District Office (NYK-DO) |
| 5/1/2009 | 75CGAGLUCOSE OXIDASE, GLUCOSE | 341REGISTERED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is LifeScan Scotland LTD.'s FDA import refusal history?
LifeScan Scotland LTD. (FEI: 3001058982) has 7 FDA import refusal record(s) in our database, spanning from 5/1/2009 to 2/2/2012.
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. LifeScan Scotland LTD.'s FEI number is 3001058982.
What types of violations has LifeScan Scotland LTD. received?
LifeScan Scotland LTD. has been cited for 6 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 LifeScan Scotland LTD. come from?
All FDA import refusal data for LifeScan Scotland 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.