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Alcon Laboratories India Pvt Ltd

⚠️ Moderate Risk

FEI: 3006974359 • Bangalore, Karnataka • INDIA

FEI

FEI Number

3006974359

📍

Location

Bangalore, Karnataka

🇮🇳

Country

INDIA
🏢

Address

5th Floor Unit No 502, Tower Drmz, Bangalore, Karnataka, India

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
7/14/2011
Latest Refusal
7/14/2011
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
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

751×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
7/14/2011
56ODK02MOXIFLOXACIN HCL (FLUOROQUINOLONE)
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Alcon Laboratories India Pvt Ltd's FDA import refusal history?

Alcon Laboratories India Pvt Ltd (FEI: 3006974359) has 1 FDA import refusal record(s) in our database, spanning from 7/14/2011 to 7/14/2011.

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 Laboratories India Pvt Ltd's FEI number is 3006974359.

What types of violations has Alcon Laboratories India Pvt Ltd received?

Alcon Laboratories India Pvt Ltd 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 Alcon Laboratories India Pvt Ltd come from?

All FDA import refusal data for Alcon Laboratories India Pvt Ltd 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.