SUNMAX VIETNAM CO LTD
⚠️ Moderate Risk
FEI: 3007529450 • Hai Phong, Hai Phong • VIETNAM
FEI Number
3007529450
Location
Hai Phong, Hai Phong
Country
VIETNAMAddress
Hai Thanh Doung Kinh District, Km 8, Pham Van Dong; Quan Do Son, Hai Phong, Hai Phong, 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
DE IMP GMP
The article is subject to refusal of admission pursuant to section 801(a)(1) in that it appears that the methods used in, or the facilities or controls used for, the manufacture of the device do not conform to the applicable requirements of section 520(f).
DV QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
Refusal History
Frequently Asked Questions
What is SUNMAX VIETNAM CO LTD's FDA import refusal history?
SUNMAX VIETNAM CO LTD (FEI: 3007529450) has 1 FDA import refusal record(s) in our database, spanning from 3/20/2015 to 3/20/2015.
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. SUNMAX VIETNAM CO LTD's FEI number is 3007529450.
What types of violations has SUNMAX VIETNAM CO LTD received?
SUNMAX VIETNAM 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 SUNMAX VIETNAM CO LTD come from?
All FDA import refusal data for SUNMAX VIETNAM 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.