Veredus Laboratories Pte Ltd
✅ Low Risk
FEI: 3009158989 • Singapore • SINGAPORE
FEI Number
3009158989
Location
Singapore
Country
SINGAPOREAddress
83 Science Park Drive{the Curie, , Singapore, , Singapore
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity 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).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/5/2014 | 83OQW2009 H1N1 INFLUENZA VIRUS (SWINE ORIGIN), NUCLEIC ACID OR ANTIGEN, DETECTION AND IDENTIFICATION | Division of Southeast Imports (DSEI) | |
| 8/5/2014 | 83OQW2009 H1N1 INFLUENZA VIRUS (SWINE ORIGIN), NUCLEIC ACID OR ANTIGEN, DETECTION AND IDENTIFICATION | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Veredus Laboratories Pte Ltd's FDA import refusal history?
Veredus Laboratories Pte Ltd (FEI: 3009158989) has 2 FDA import refusal record(s) in our database, spanning from 8/5/2014 to 8/5/2014.
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. Veredus Laboratories Pte Ltd's FEI number is 3009158989.
What types of violations has Veredus Laboratories Pte Ltd received?
Veredus Laboratories 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 Veredus Laboratories Pte Ltd come from?
All FDA import refusal data for Veredus Laboratories 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.