ETG INTERNATIONAL (SG) PTE LTD
⚠️ Moderate Risk
FEI: 3012897979 • Singapore • SINGAPORE
FEI Number
3012897979
Location
Singapore
Country
SINGAPOREAddress
23 Kaki Bukit Road 4, Synergy @ Kb, Singapore, , Singapore
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).
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).
Refusal History
Frequently Asked Questions
What is ETG INTERNATIONAL (SG) PTE LTD's FDA import refusal history?
ETG INTERNATIONAL (SG) PTE LTD (FEI: 3012897979) has 1 FDA import refusal record(s) in our database, spanning from 1/24/2017 to 1/24/2017.
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. ETG INTERNATIONAL (SG) PTE LTD's FEI number is 3012897979.
What types of violations has ETG INTERNATIONAL (SG) PTE LTD received?
ETG INTERNATIONAL (SG) 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 ETG INTERNATIONAL (SG) PTE LTD come from?
All FDA import refusal data for ETG INTERNATIONAL (SG) 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.