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Kontur Kontact Lens Co., Inc.

✅ Low Risk

FEI: 2919245 • Hercules, CA • UNITED STATES

FEI

FEI Number

2919245

📍

Location

Hercules, CA

🇺🇸
🏢

Address

642 Alfred Nobel Dr, , Hercules, CA, United States

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
1
Unique Violations
11/16/2010
Latest Refusal
11/16/2010
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
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).

Refusal History

DateProductViolationsDivision
11/16/2010
86LPLLENSES, SOFT CONTACT, DAILY WEAR
118NOT LISTED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Kontur Kontact Lens Co., Inc.'s FDA import refusal history?

Kontur Kontact Lens Co., Inc. (FEI: 2919245) has 1 FDA import refusal record(s) in our database, spanning from 11/16/2010 to 11/16/2010.

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. Kontur Kontact Lens Co., Inc.'s FEI number is 2919245.

What types of violations has Kontur Kontact Lens Co., Inc. received?

Kontur Kontact Lens Co., 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 Kontur Kontact Lens Co., Inc. come from?

All FDA import refusal data for Kontur Kontact Lens Co., 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.