HANGZHOU FORMED MEDICAL DEVICE C
⚠️ Moderate Risk
FEI: 3013974389 • Hangzhou, Zhejiang • CHINA
FEI Number
3013974389
Location
Hangzhou, Zhejiang
Country
CHINAAddress
Building 3, No. 292 Gong, 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
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
Frequently Asked Questions
What is HANGZHOU FORMED MEDICAL DEVICE C's FDA import refusal history?
HANGZHOU FORMED MEDICAL DEVICE C (FEI: 3013974389) has 1 FDA import refusal record(s) in our database, spanning from 12/5/2023 to 12/5/2023.
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. HANGZHOU FORMED MEDICAL DEVICE C's FEI number is 3013974389.
What types of violations has HANGZHOU FORMED MEDICAL DEVICE C received?
HANGZHOU FORMED MEDICAL DEVICE C 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 HANGZHOU FORMED MEDICAL DEVICE C come from?
All FDA import refusal data for HANGZHOU FORMED MEDICAL DEVICE C 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.