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Alcon Labs Inc

Low Risk

FEI: 3000240329 • Fort Worth, TX • UNITED STATES

FEI

FEI Number

3000240329

📍

Location

Fort Worth, TX

🇺🇸
🏢

Address

6500 Will Rogers Blvd, , Fort Worth, TX, 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
2
Unique Violations
3/14/2019
Latest Refusal
3/14/2019
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

24801×

RXPERSONAL

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

32601×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)

Refusal History

DateProductViolationsDivision
3/14/2019
86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY
2480RXPERSONAL
3260NO ENGLISH
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Alcon Labs Inc's FDA import refusal history?

Alcon Labs Inc (FEI: 3000240329) has 1 FDA import refusal record(s) in our database, spanning from 3/14/2019 to 3/14/2019.

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. Alcon Labs Inc's FEI number is 3000240329.

What types of violations has Alcon Labs Inc received?

Alcon Labs 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 Alcon Labs Inc come from?

All FDA import refusal data for Alcon Labs 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.