CooperVision, Inc.
⚠️ Moderate Risk
FEI: 1118577 • Norfolk, VA • UNITED STATES
FEI Number
1118577
Location
Norfolk, VA
Country
UNITED STATESAddress
1215 Boissevain Ave, , Norfolk, VA, 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
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).
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.
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
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 |
|---|---|---|---|
| 8/9/2005 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 16DIRECTIONS | Florida District Office (FLA-DO) |
| 1/6/2005 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 237NO PMA | New Orleans District Office (NOL-DO) |
| 4/30/2004 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Division of Southeast Imports (DSEI) | |
| 1/8/2004 | 86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is CooperVision, Inc.'s FDA import refusal history?
CooperVision, Inc. (FEI: 1118577) has 4 FDA import refusal record(s) in our database, spanning from 1/8/2004 to 8/9/2005.
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 1118577.
What types of violations has CooperVision, Inc. received?
CooperVision, Inc. has been cited for 7 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.