SHANGHAI MEWON MEDICAL CO., LTD.
⚠️ High Risk
FEI: 3035221284 • Shanghai, Shanghai • CHINA
FEI Number
3035221284
Location
Shanghai, Shanghai
Country
CHINAAddress
Building Room 1202, 4 Lane 5000 Gonghexin Road; Baoshan, Shanghai, Shanghai, 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
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/18/2025 | 79ERYDRAPE, SURGICAL, ENT | Division of West Coast Imports (DWCI) | |
| 7/18/2025 | 79ERYDRAPE, SURGICAL, ENT | Division of West Coast Imports (DWCI) | |
| 7/18/2025 | 79ERYDRAPE, SURGICAL, ENT | Division of West Coast Imports (DWCI) | |
| 7/18/2025 | 79ERYDRAPE, SURGICAL, ENT | Division of West Coast Imports (DWCI) | |
| 7/18/2025 | 79ERYDRAPE, SURGICAL, ENT | Division of West Coast Imports (DWCI) | |
| 7/18/2025 | 79ERYDRAPE, SURGICAL, ENT | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is SHANGHAI MEWON MEDICAL CO., LTD.'s FDA import refusal history?
SHANGHAI MEWON MEDICAL CO., LTD. (FEI: 3035221284) has 6 FDA import refusal record(s) in our database, spanning from 7/18/2025 to 7/18/2025.
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. SHANGHAI MEWON MEDICAL CO., LTD.'s FEI number is 3035221284.
What types of violations has SHANGHAI MEWON MEDICAL CO., LTD. received?
SHANGHAI MEWON MEDICAL 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 SHANGHAI MEWON MEDICAL CO., LTD. come from?
All FDA import refusal data for SHANGHAI MEWON MEDICAL 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.