Wuxi Biologics Co Ltd
⚠️ High Risk
FEI: 3010606982 • Wuxi, Jiangsu • CHINA
FEI Number
3010606982
Location
Wuxi, Jiangsu
Country
CHINAAddress
108 Meiliang Road, Binhu, 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
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).
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 |
|---|---|---|---|
| 9/3/2025 | 58DCP99ANTINEOPLASTIC, NEC | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 4/28/2022 | 62FIK99ANTI-INFECTIVE, TOPICAL N.E.C. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 8/21/2017 | 66YRR99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 16DIRECTIONS | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is Wuxi Biologics Co Ltd's FDA import refusal history?
Wuxi Biologics Co Ltd (FEI: 3010606982) has 3 FDA import refusal record(s) in our database, spanning from 8/21/2017 to 9/3/2025.
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 Biologics Co Ltd's FEI number is 3010606982.
What types of violations has Wuxi Biologics Co Ltd received?
Wuxi Biologics 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 Biologics Co Ltd come from?
All FDA import refusal data for Wuxi Biologics 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.