HANGZHOU WESTLAKE BIOMATERIAL CO
⚠️ Moderate Risk
FEI: 3015402280 • Hangzhou • CHINA
FEI Number
3015402280
Location
Hangzhou
Country
CHINAAddress
Bld 2 No 1 Lingang Rd R, , Hangzhou, , 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
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/31/2024 | 80FXXMASK, SURGICAL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 7/31/2024 | 76DYJRETAINER, SCREW EXPANSION, ORTHODONTIC | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 7/31/2024 | 76ECMBAND, PREFORMED, ORTHODONTIC | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 7/31/2024 | 76EJFBRACKET, METAL, ORTHODONTIC | 341REGISTERED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is HANGZHOU WESTLAKE BIOMATERIAL CO's FDA import refusal history?
HANGZHOU WESTLAKE BIOMATERIAL CO (FEI: 3015402280) has 4 FDA import refusal record(s) in our database, spanning from 7/31/2024 to 7/31/2024.
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 WESTLAKE BIOMATERIAL CO's FEI number is 3015402280.
What types of violations has HANGZHOU WESTLAKE BIOMATERIAL CO received?
HANGZHOU WESTLAKE BIOMATERIAL CO 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 HANGZHOU WESTLAKE BIOMATERIAL CO come from?
All FDA import refusal data for HANGZHOU WESTLAKE BIOMATERIAL CO 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.