ImportRefusal LogoImportRefusal

Coopervision

⚠️ Moderate Risk

FEI: 3012177179 • Guatemala, Guatemala • GUATEMALA

FEI

FEI Number

3012177179

📍

Location

Guatemala, Guatemala

🇬🇹

Country

GUATEMALA
🏢

Address

7 Ave. 14-44 z. 13, , Guatemala, Guatemala, Guatemala

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
5/2/2016
Latest Refusal
5/2/2016
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

161×

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.

24801×

RXPERSONAL

The article appears to be a device which requires a prescription from your doctor.

Refusal History

DateProductViolationsDivision
5/2/2016
86MWLLENS, CONTACT (RIGID GAS PERMEABLE) - EXTENDED WEAR
16DIRECTIONS
2480RXPERSONAL
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Coopervision's FDA import refusal history?

Coopervision (FEI: 3012177179) has 1 FDA import refusal record(s) in our database, spanning from 5/2/2016 to 5/2/2016.

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's FEI number is 3012177179.

What types of violations has Coopervision received?

Coopervision 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 come from?

All FDA import refusal data for Coopervision 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.