CooperVision Limited
⚠️ Moderate Risk
FEI: 3002807783 • Eastleigh, Hampshire • UNITED KINGDOM
FEI Number
3002807783
Location
Eastleigh, Hampshire
Country
UNITED KINGDOMAddress
36 School Lane, , Eastleigh, Hampshire, 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).
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).
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).
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.
STERILITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/25/2014 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 3280FRNMFGREG | Cincinnati District Office (CIN-DO) |
| 10/26/2010 | 86LPMLENSES, SOFT CONTACT, EXTENDED WEAR | 341REGISTERED | Florida District Office (FLA-DO) |
| 7/5/2007 | 86MVNLENS, CONTACT (DISPOSABLE) | 78STERILITY | New York District Office (NYK-DO) |
| 3/19/2004 | 86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY | Cincinnati District Office (CIN-DO) | |
| 12/16/2003 | 86LPMLENSES, SOFT CONTACT, EXTENDED WEAR | 2380NO PMA/PDP | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is CooperVision Limited's FDA import refusal history?
CooperVision Limited (FEI: 3002807783) has 5 FDA import refusal record(s) in our database, spanning from 12/16/2003 to 8/25/2014.
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. CooperVision Limited's FEI number is 3002807783.
What types of violations has CooperVision Limited received?
CooperVision Limited 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 CooperVision Limited come from?
All FDA import refusal data for CooperVision 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.