Coopervision Inc.
⚠️ Moderate Risk
FEI: 1000430350 • Fairport, NY • UNITED STATES
FEI Number
1000430350
Location
Fairport, NY
Country
UNITED STATESAddress
370 Woodcliff Dr Ste 200, , Fairport, NY, United States
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.
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.
RX DEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/21/2014 | 86MVNLENS, CONTACT (DISPOSABLE) | 3280FRNMFGREG | Cincinnati District Office (CIN-DO) |
| 8/20/2014 | 86MVNLENS, CONTACT (DISPOSABLE) | 3280FRNMFGREG | Cincinnati District Office (CIN-DO) |
| 8/21/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 8/21/2013 | 86MVNLENS, CONTACT (DISPOSABLE) | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 6/20/2004 | 86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY | 84RX DEVICE | New Orleans District Office (NOL-DO) |
| 1/8/2002 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 508NO 510(K) | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Coopervision Inc.'s FDA import refusal history?
Coopervision Inc. (FEI: 1000430350) has 6 FDA import refusal record(s) in our database, spanning from 1/8/2002 to 8/21/2014.
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 Inc.'s FEI number is 1000430350.
What types of violations has Coopervision Inc. received?
Coopervision Inc. 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 Inc. come from?
All FDA import refusal data for Coopervision Inc. 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.