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Alcon Research, LTD.

⚠️ High Risk

FEI: 2523835 • Sinking Spring, PA • UNITED STATES

FEI

FEI Number

2523835

📍

Location

Sinking Spring, PA

🇺🇸
🏢

Address

714 Columbia Ave, , Sinking Spring, PA, United States

High Risk

FDA Import Risk Assessment

53.1
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

2
Total Refusals
2
Unique Violations
12/11/2025
Latest Refusal
4/8/2002
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
17.7×30%
Recency
98.4×20%
Frequency
0.8×10%
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).

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
12/11/2025
86HQCUNIT, PHACOFRAGMENTATION
118NOT LISTED
Division of Southwest Imports (DSWI)
4/8/2002
66VAS99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Philadelphia District Office (PHI-DO)

Frequently Asked Questions

What is Alcon Research, LTD.'s FDA import refusal history?

Alcon Research, LTD. (FEI: 2523835) has 2 FDA import refusal record(s) in our database, spanning from 4/8/2002 to 12/11/2025.

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 Research, LTD.'s FEI number is 2523835.

What types of violations has Alcon Research, LTD. received?

Alcon Research, LTD. 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 Research, LTD. come from?

All FDA import refusal data for Alcon Research, 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.