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Coopervision Inc

⚠️ Moderate Risk

FEI: 1317293 • Rochester, NY • UNITED STATES

FEI

FEI Number

1317293

📍

Location

Rochester, NY

🇺🇸
🏢

Address

3495 Winton Pl, , Rochester, NY, United States

Moderate Risk

FDA Import Risk Assessment

30.3
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

1
Total Refusals
2
Unique Violations
10/18/2002
Latest Refusal
10/18/2002
Earliest Refusal

Score Breakdown

Violation Severity
65.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

1181×

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).

23801×

NO PMA/PDP

The article appears to be a class III dev.w/o an approved applic. for premarket approval, and/or a notice of completion of product development protocol filed per section 515(b) or exempt per sect.520(g)(1).

Refusal History

DateProductViolationsDivision
10/18/2002
86LPMLENSES, SOFT CONTACT, EXTENDED WEAR
118NOT LISTED
2380NO PMA/PDP
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is Coopervision Inc's FDA import refusal history?

Coopervision Inc (FEI: 1317293) has 1 FDA import refusal record(s) in our database, spanning from 10/18/2002 to 10/18/2002.

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 1317293.

What types of violations has Coopervision Inc received?

Coopervision Inc has been cited for 2 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.