Terumo Medical Products (Hangzhou) Co., Ltd.
⚠️ Moderate Risk
FEI: 3004102031 • Hangzhou, Zhejiang • CHINA
FEI Number
3004102031
Location
Hangzhou, Zhejiang
Country
CHINAAddress
5 M4-9 Economic & Technological, Development Zone, Hangzhou, Zhejiang, 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.
Refusal History
Frequently Asked Questions
What is Terumo Medical Products (Hangzhou) Co., Ltd.'s FDA import refusal history?
Terumo Medical Products (Hangzhou) Co., Ltd. (FEI: 3004102031) has 2 FDA import refusal record(s) in our database, spanning from 8/28/2012 to 8/28/2012.
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. Terumo Medical Products (Hangzhou) Co., Ltd.'s FEI number is 3004102031.
What types of violations has Terumo Medical Products (Hangzhou) Co., Ltd. received?
Terumo Medical Products (Hangzhou) 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 Terumo Medical Products (Hangzhou) Co., Ltd. come from?
All FDA import refusal data for Terumo Medical Products (Hangzhou) 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.