Wuxi Fortune Pharmaceutical Co., Ltd.
⚠️ High Risk
FEI: 3005968356 • Wuxi, Jiangsu • CHINA
FEI Number
3005968356
Location
Wuxi, Jiangsu
Country
CHINAAddress
No. 2 Rongyang 1st Road, Xishan Economic Zone, Wuxi, Jiangsu, China
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable 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).
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 Wuxi Fortune Pharmaceutical Co., Ltd.'s FDA import refusal history?
Wuxi Fortune Pharmaceutical Co., Ltd. (FEI: 3005968356) has 1 FDA import refusal record(s) in our database, spanning from 11/24/2025 to 11/24/2025.
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. Wuxi Fortune Pharmaceutical Co., Ltd.'s FEI number is 3005968356.
What types of violations has Wuxi Fortune Pharmaceutical Co., Ltd. received?
Wuxi Fortune 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 Wuxi Fortune Pharmaceutical Co., Ltd. come from?
All FDA import refusal data for Wuxi Fortune 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.