XIAN SHENGHUI KANGZE BIOLOGY SCI
⚠️ Moderate Risk
FEI: 3031906947 • Xian • CHINA
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
LACKS FIRM
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Refusal History
Frequently Asked Questions
What is XIAN SHENGHUI KANGZE BIOLOGY SCI's FDA import refusal history?
XIAN SHENGHUI KANGZE BIOLOGY SCI (FEI: 3031906947) has 1 FDA import refusal record(s) in our database, spanning from 9/20/2024 to 9/20/2024.
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. XIAN SHENGHUI KANGZE BIOLOGY SCI's FEI number is 3031906947.
What types of violations has XIAN SHENGHUI KANGZE BIOLOGY SCI received?
XIAN SHENGHUI KANGZE BIOLOGY SCI 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 XIAN SHENGHUI KANGZE BIOLOGY SCI come from?
All FDA import refusal data for XIAN SHENGHUI KANGZE BIOLOGY SCI 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.