HAI THINH INVESTMENT NEW TECHNOLOGY JOINT STOCK COMPANY
⚠️ Moderate Risk
FEI: 3016824907 • THANH PHO • VIETNAM
FEI Number
3016824907
Location
THANH PHO
Country
VIETNAMAddress
Nv1-18 Dreamtown Urban Area, Tay Mo Ward, Nam Tu Liem District, Ha Noi, THANH PHO,, 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
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
Frequently Asked Questions
What is HAI THINH INVESTMENT NEW TECHNOLOGY JOINT STOCK COMPANY's FDA import refusal history?
HAI THINH INVESTMENT NEW TECHNOLOGY JOINT STOCK COMPANY (FEI: 3016824907) has 1 FDA import refusal record(s) in our database, spanning from 10/19/2020 to 10/19/2020.
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. HAI THINH INVESTMENT NEW TECHNOLOGY JOINT STOCK COMPANY's FEI number is 3016824907.
What types of violations has HAI THINH INVESTMENT NEW TECHNOLOGY JOINT STOCK COMPANY received?
HAI THINH INVESTMENT NEW TECHNOLOGY JOINT STOCK COMPANY has been cited for 3 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 HAI THINH INVESTMENT NEW TECHNOLOGY JOINT STOCK COMPANY come from?
All FDA import refusal data for HAI THINH INVESTMENT NEW TECHNOLOGY JOINT STOCK COMPANY 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.