TTI CO.,LTD
⚠️ Moderate Risk
FEI: 3015129053 • Hcm City • VIETNAM
FEI Number
3015129053
Location
Hcm City
Country
VIETNAMAddress
E31 Cx Phu Lam C, Str N, , Hcm City, , Vietnam
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).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
Refusal History
Frequently Asked Questions
What is TTI CO.,LTD's FDA import refusal history?
TTI CO.,LTD (FEI: 3015129053) has 1 FDA import refusal record(s) in our database, spanning from 3/10/2020 to 3/10/2020.
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. TTI CO.,LTD's FEI number is 3015129053.
What types of violations has TTI CO.,LTD received?
TTI CO.,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 TTI CO.,LTD come from?
All FDA import refusal data for TTI CO.,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.