Alcon Laboratories Philippines Inc
⚠️ Moderate Risk
FEI: 3005399222 • Metro Manila • PHILIPPINES
FEI Number
3005399222
Location
Metro Manila
Country
PHILIPPINESAddress
Ortigas Avenue, , Metro Manila, , Philippines
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).
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
Frequently Asked Questions
What is Alcon Laboratories Philippines Inc's FDA import refusal history?
Alcon Laboratories Philippines Inc (FEI: 3005399222) has 2 FDA import refusal record(s) in our database, spanning from 11/18/2005 to 8/6/2009.
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 Philippines Inc's FEI number is 3005399222.
What types of violations has Alcon Laboratories Philippines Inc received?
Alcon Laboratories Philippines Inc 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 Laboratories Philippines Inc come from?
All FDA import refusal data for Alcon Laboratories Philippines Inc 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.