CooperVision, Inc.
⚠️ High Risk
FEI: 3005724763 • West Henrietta, NY • UNITED STATES
FEI
FEI Number
3005724763
📍
Location
West Henrietta, NY
🇺🇸
Country
UNITED STATES🏢
Address
180 Thruway Park Dr, , West Henrietta, NY, United States
High Risk
FDA Import Risk Assessment
59.0
LowModerateHighCritical
This firm has a significant history of FDA import refusals with notable violations.
Statistics
82
Total Refusals
3
Unique Violations
4/4/2014
Latest Refusal
2/17/2012
Earliest Refusal
Score Breakdown
Violation Severity
69.3×40%
Refusal Volume
71.1×30%
Recency
0.0×20%
Frequency
100.0×10%
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
1680×
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.
32801×
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.
3411×
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 |
|---|---|---|---|
| 4/4/2014 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 3280FRNMFGREG | Cincinnati District Office (CIN-DO) |
| 8/27/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 8/27/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 8/27/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 8/27/2013 | 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) |
| 8/22/2013 | 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) |
| 8/22/2013 | 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) |
| 8/22/2013 | 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) |
| 8/22/2013 | 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) |
| 8/22/2013 | 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) |
| 8/22/2013 | 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) |
| 8/21/2013 | 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) |
| 8/21/2013 | 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) |
| 8/21/2013 | 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) |
| 8/21/2013 | 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) |
| 8/21/2013 | 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) |
| 2/17/2012 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 341REGISTERED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is CooperVision, Inc.'s FDA import refusal history?
CooperVision, Inc. (FEI: 3005724763) has 82 FDA import refusal record(s) in our database, spanning from 2/17/2012 to 4/4/2014.
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 3005724763.
What types of violations has CooperVision, Inc. received?
CooperVision, Inc. has been cited for 3 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.