Coopervision Manufacturing, Ltd
⚠️ Moderate Risk
FEI: 3003981983 • Eastleigh, Hampshire • UNITED KINGDOM
FEI Number
3003981983
Location
Eastleigh, Hampshire
Country
UNITED KINGDOMAddress
Erith House, Warrior Close, 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
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.
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/18/2016 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 5/17/2016 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 3280FRNMFGREG | Florida District Office (FLA-DO) |
| 1/7/2016 | 86LPMLENSES, SOFT CONTACT, EXTENDED WEAR | 16DIRECTIONS | Florida District Office (FLA-DO) |
| 1/7/2016 | 86LPMLENSES, SOFT CONTACT, EXTENDED WEAR | 16DIRECTIONS | Florida District Office (FLA-DO) |
| 1/5/2016 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 16DIRECTIONS | Florida District Office (FLA-DO) |
| 10/22/2015 | 86LPMLENSES, SOFT CONTACT, EXTENDED WEAR | Cincinnati District Office (CIN-DO) | |
| 10/22/2015 | 86MVNLENS, CONTACT (DISPOSABLE) | Cincinnati District Office (CIN-DO) | |
| 10/19/2015 | 86LPMLENSES, SOFT CONTACT, EXTENDED WEAR | 16DIRECTIONS | Florida District Office (FLA-DO) |
| 10/16/2015 | 86LPMLENSES, SOFT CONTACT, EXTENDED WEAR | 16DIRECTIONS | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Coopervision Manufacturing, Ltd's FDA import refusal history?
Coopervision Manufacturing, Ltd (FEI: 3003981983) has 9 FDA import refusal record(s) in our database, spanning from 10/16/2015 to 7/18/2016.
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 Manufacturing, Ltd's FEI number is 3003981983.
What types of violations has Coopervision Manufacturing, Ltd received?
Coopervision Manufacturing, Ltd has been cited for 4 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 Manufacturing, Ltd come from?
All FDA import refusal data for Coopervision Manufacturing, 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.