Coopervision Inc
⚠️ Moderate Risk
FEI: 3008692993 • Pleasanton, CA • UNITED STATES
FEI Number
3008692993
Location
Pleasanton, CA
Country
UNITED STATESAddress
6150 Stoneridge Mall Rd Ste 370, , Pleasanton, CA, 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
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/26/2014 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 3280FRNMFGREG | Cincinnati District Office (CIN-DO) |
| 8/25/2014 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 3280FRNMFGREG | Cincinnati District Office (CIN-DO) |
| 8/22/2014 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 3280FRNMFGREG | Cincinnati District Office (CIN-DO) |
| 8/22/2014 | 86MVNLENS, CONTACT (DISPOSABLE) | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 8/22/2014 | 86MVNLENS, CONTACT (DISPOSABLE) | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 8/22/2014 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 3280FRNMFGREG | Cincinnati District Office (CIN-DO) |
| 8/22/2014 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 3280FRNMFGREG | Cincinnati District Office (CIN-DO) |
| 8/20/2014 | 86MVNLENS, CONTACT (DISPOSABLE) | 3280FRNMFGREG | Cincinnati District Office (CIN-DO) |
| 8/15/2014 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 3280FRNMFGREG | Cincinnati District Office (CIN-DO) |
| 4/23/2014 | 86MVNLENS, CONTACT (DISPOSABLE) | 3280FRNMFGREG | Cincinnati District Office (CIN-DO) |
| 4/3/2014 | 86MVNLENS, CONTACT (DISPOSABLE) | 3280FRNMFGREG | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Coopervision Inc's FDA import refusal history?
Coopervision Inc (FEI: 3008692993) has 11 FDA import refusal record(s) in our database, spanning from 4/3/2014 to 8/26/2014.
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 3008692993.
What types of violations has Coopervision Inc received?
Coopervision Inc has been cited for 1 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.