ALCON LABORATORIES
⚠️ Moderate Risk
FEI: 3013208399 • Kaysersberg, Haut Rhin • FRANCE
FEI Number
3013208399
Location
Kaysersberg, Haut Rhin
Country
FRANCEAddress
15 avenue Georges Ferrenbach, , Kaysersberg, Haut Rhin, France
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
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 PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
NO PMA/PDP
The article appears to be a class III dev.w/o an approved applic. for premarket approval, and/or a notice of completion of product development protocol filed per section 515(b) or exempt per sect.520(g)(1).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/10/2018 | 86LYLACCESSORIES TO CONTACT LENS SOLUTION | Division of Southeast Imports (DSEI) | |
| 2/14/2018 | 86LPMLENSES, SOFT CONTACT, EXTENDED WEAR | Division of Southeast Imports (DSEI) | |
| 2/14/2018 | 86LPMLENSES, SOFT CONTACT, EXTENDED WEAR | Division of Southeast Imports (DSEI) | |
| 8/24/2017 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is ALCON LABORATORIES's FDA import refusal history?
ALCON LABORATORIES (FEI: 3013208399) has 4 FDA import refusal record(s) in our database, spanning from 8/24/2017 to 4/10/2018.
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's FEI number is 3013208399.
What types of violations has ALCON LABORATORIES received?
ALCON LABORATORIES 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 come from?
All FDA import refusal data for ALCON LABORATORIES 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.