Shaanxi Combine Medicines and Health Products Co., Ltd.
⚠️ Moderate Risk
FEI: 3003991595 • Xian, Shanxi • CHINA
FEI Number
3003991595
Location
Xian, Shanxi
Country
CHINAAddress
No 37 Lianhu Road, , 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
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/15/2009 | 62VCS01AMANTADINE HCL (ANTI-VIRAL) | 16DIRECTIONS | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Shaanxi Combine Medicines and Health Products Co., Ltd.'s FDA import refusal history?
Shaanxi Combine Medicines and Health Products Co., Ltd. (FEI: 3003991595) has 1 FDA import refusal record(s) in our database, spanning from 6/15/2009 to 6/15/2009.
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. Shaanxi Combine Medicines and Health Products Co., Ltd.'s FEI number is 3003991595.
What types of violations has Shaanxi Combine Medicines and Health Products Co., Ltd. received?
Shaanxi Combine Medicines and Health Products Co., Ltd. has been cited for 1 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 Shaanxi Combine Medicines and Health Products Co., Ltd. come from?
All FDA import refusal data for Shaanxi Combine Medicines and Health Products 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.