XIAN SHUNKANG PHARMACEUTICAL CO LTD
⚠️ Moderate Risk
FEI: 2000018686 • Xian, Shanxi • CHINA
FEI Number
2000018686
Location
Xian, Shanxi
Country
CHINAAddress
49 Shuncheng North Rd West Section, , Xian, Shanxi, 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
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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 SHUNKANG PHARMACEUTICAL CO LTD's FDA import refusal history?
XIAN SHUNKANG PHARMACEUTICAL CO LTD (FEI: 2000018686) has 1 FDA import refusal record(s) in our database, spanning from 11/8/2006 to 11/8/2006.
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 SHUNKANG PHARMACEUTICAL CO LTD's FEI number is 2000018686.
What types of violations has XIAN SHUNKANG PHARMACEUTICAL CO LTD received?
XIAN SHUNKANG PHARMACEUTICAL 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 XIAN SHUNKANG PHARMACEUTICAL CO LTD come from?
All FDA import refusal data for XIAN SHUNKANG PHARMACEUTICAL 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.