Jiangsu Yunyang Group Pharmaceutical Co.,Ltd.
⚠️ Moderate Risk
FEI: 3005420636 • Zhenjiang, Jiangsu • CHINA
FEI Number
3005420636
Location
Zhenjiang, Jiangsu
Country
CHINAAddress
8 Bawei Road, Danyang Jingjikaifa Danyang, Zhenjiang, Jiangsu, 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
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).
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
Frequently Asked Questions
What is Jiangsu Yunyang Group Pharmaceutical Co.,Ltd.'s FDA import refusal history?
Jiangsu Yunyang Group Pharmaceutical Co.,Ltd. (FEI: 3005420636) has 1 FDA import refusal record(s) in our database, spanning from 11/28/2012 to 11/28/2012.
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. Jiangsu Yunyang Group Pharmaceutical Co.,Ltd.'s FEI number is 3005420636.
What types of violations has Jiangsu Yunyang Group Pharmaceutical Co.,Ltd. received?
Jiangsu Yunyang Group 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 Jiangsu Yunyang Group Pharmaceutical Co.,Ltd. come from?
All FDA import refusal data for Jiangsu Yunyang Group 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.