Alcon Laboratories Inc 6
⚠️ High Risk
FEI: 3005652917 • Fort Worth, TX • UNITED STATES
FEI Number
3005652917
Location
Fort Worth, TX
Country
UNITED STATESAddress
International Import/Export Dept, 201 South Freeway Am-4, Fort Worth, TX, United States
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
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).
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/27/2025 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Division of Southeast Imports (DSEI) | |
| 10/22/2024 | 86LPMLENSES, SOFT CONTACT, EXTENDED WEAR | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/18/2023 | 86MVNLENS, CONTACT (DISPOSABLE) | Division of Southeast Imports (DSEI) | |
| 8/25/2023 | 63HCL25POLYETHYLENE GLYCOL 3350/ELECTROLYTES (CARTHARTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/22/2023 | 60CDK46NAPHAZOLINE HCL (ADRENERGIC) | 179AGR RX | Division of West Coast Imports (DWCI) |
| 10/19/2022 | 86LPMLENSES, SOFT CONTACT, EXTENDED WEAR | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Alcon Laboratories Inc 6's FDA import refusal history?
Alcon Laboratories Inc 6 (FEI: 3005652917) has 6 FDA import refusal record(s) in our database, spanning from 10/19/2022 to 10/27/2025.
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 Laboratories Inc 6's FEI number is 3005652917.
What types of violations has Alcon Laboratories Inc 6 received?
Alcon Laboratories Inc 6 has been cited for 5 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 Inc 6 come from?
All FDA import refusal data for Alcon Laboratories Inc 6 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.