ALCON LABORATUVARLARI
⚠️ Moderate Risk
FEI: 3012637155 • ISTANBUL • TURKEY
FEI Number
3012637155
Location
ISTANBUL
Country
TURKEYAddress
NO.18 B-BLOK KAT 1, , ISTANBUL, , Turkey
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/24/2020 | 66RBL08BRINZOLAMIDE (VASOCONSTRICTOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/26/2018 | 61LDK40TRAVOPROST (ANTI-COAGULANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/26/2018 | 66RCK08BRINZOLAMIDE (VASOCONSTRICTOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/21/2016 | 61LCK40TRAVOPROST (ANTI-COAGULANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is ALCON LABORATUVARLARI's FDA import refusal history?
ALCON LABORATUVARLARI (FEI: 3012637155) has 4 FDA import refusal record(s) in our database, spanning from 11/21/2016 to 4/24/2020.
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 LABORATUVARLARI's FEI number is 3012637155.
What types of violations has ALCON LABORATUVARLARI received?
ALCON LABORATUVARLARI 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 LABORATUVARLARI come from?
All FDA import refusal data for ALCON LABORATUVARLARI 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.