Alcon Singapore Manufacturing Pte Ltd.
⚠️ High Risk
FEI: 3010372291 • Singapore • SINGAPORE
FEI Number
3010372291
Location
Singapore
Country
SINGAPOREAddress
19 Tuas South Avenue 14, , Singapore, , Singapore
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
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/9/2025 | 64LDL19DEXAMETHASONE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/18/2024 | 64DDL02POLYETHYLENE GLYCOL, EMOLLIENT,LUBRICANT | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/30/2022 | 86MSISOLUTION, CLEANING/LUBRICATING, ARTICIFIAL EYE | 3260NO ENGLISH | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Alcon Singapore Manufacturing Pte Ltd.'s FDA import refusal history?
Alcon Singapore Manufacturing Pte Ltd. (FEI: 3010372291) has 3 FDA import refusal record(s) in our database, spanning from 11/30/2022 to 10/9/2025.
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 Singapore Manufacturing Pte Ltd.'s FEI number is 3010372291.
What types of violations has Alcon Singapore Manufacturing Pte Ltd. received?
Alcon Singapore Manufacturing Pte 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 Singapore Manufacturing Pte Ltd. come from?
All FDA import refusal data for Alcon Singapore Manufacturing Pte 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.