XIAN PLANT BIO-ENGINEERING
✅ Low Risk
FEI: 3012668950 • XIAN SHAANIXI • CHINA
FEI Number
3012668950
Location
XIAN SHAANIXI
Country
CHINAAddress
ROOM 10740, NO 3 DUHUI, , XIAN SHAANIXI, , China
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
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 ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
Frequently Asked Questions
What is XIAN PLANT BIO-ENGINEERING's FDA import refusal history?
XIAN PLANT BIO-ENGINEERING (FEI: 3012668950) has 1 FDA import refusal record(s) in our database, spanning from 10/4/2016 to 10/4/2016.
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 PLANT BIO-ENGINEERING's FEI number is 3012668950.
What types of violations has XIAN PLANT BIO-ENGINEERING received?
XIAN PLANT BIO-ENGINEERING 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 PLANT BIO-ENGINEERING come from?
All FDA import refusal data for XIAN PLANT BIO-ENGINEERING 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.