WUXI ZHONGDE MEDICAL EQUIPMENT MANUFACTURING CO LTD
⚠️ Moderate Risk
FEI: 3016879518 • Wuxi, Jiangsu • CHINA
FEI Number
3016879518
Location
Wuxi, Jiangsu
Country
CHINAAddress
Floor 3, No 58 Zhenxing Road; Wanshizhen Yixing, Wuxi, 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
DEVICEGMPS
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.
DV QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
Frequently Asked Questions
What is WUXI ZHONGDE MEDICAL EQUIPMENT MANUFACTURING CO LTD's FDA import refusal history?
WUXI ZHONGDE MEDICAL EQUIPMENT MANUFACTURING CO LTD (FEI: 3016879518) has 1 FDA import refusal record(s) in our database, spanning from 11/30/2020 to 11/30/2020.
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 ZHONGDE MEDICAL EQUIPMENT MANUFACTURING CO LTD's FEI number is 3016879518.
What types of violations has WUXI ZHONGDE MEDICAL EQUIPMENT MANUFACTURING CO LTD received?
WUXI ZHONGDE MEDICAL EQUIPMENT MANUFACTURING CO LTD has been cited for 3 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 ZHONGDE MEDICAL EQUIPMENT MANUFACTURING CO LTD come from?
All FDA import refusal data for WUXI ZHONGDE MEDICAL EQUIPMENT MANUFACTURING 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.