Coopervision Manufacturing, Ltd.
⚠️ High Risk
FEI: 3006514242 • Fareham, Hampshire • UNITED KINGDOM
FEI Number
3006514242
Location
Fareham, Hampshire
Country
UNITED KINGDOMAddress
Delta Park, Concorde Way, Fareham, Hampshire, United Kingdom
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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.
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 |
|---|---|---|---|
| 11/21/2014 | 86HPXLENS, CONTACT (POLYMETHYLMETHACRYLATE) | 118NOT LISTED | New York District Office (NYK-DO) |
| 5/29/2014 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 3280FRNMFGREG | Cincinnati District Office (CIN-DO) |
| 2/7/2014 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | New Orleans District Office (NOL-DO) | |
| 8/22/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 8/22/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 8/22/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 8/22/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 8/22/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 8/22/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 8/21/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 8/21/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 8/21/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 8/21/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 8/21/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 8/21/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 8/21/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 8/12/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Coopervision Manufacturing, Ltd.'s FDA import refusal history?
Coopervision Manufacturing, Ltd. (FEI: 3006514242) has 17 FDA import refusal record(s) in our database, spanning from 8/12/2013 to 11/21/2014.
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 Manufacturing, Ltd.'s FEI number is 3006514242.
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.