Shanghai Sumier Im
✅ Low Risk
FEI: 3007830617 • Suzhou Jiang • CHINA
FEI Number
3007830617
Location
Suzhou Jiang
Country
CHINAAddress
666 Xiangcheng Rd, , Suzhou Jiang, , China
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/11/2012 | 85HGYPUMP, BREAST, NON-POWERED | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Shanghai Sumier Im's FDA import refusal history?
Shanghai Sumier Im (FEI: 3007830617) has 1 FDA import refusal record(s) in our database, spanning from 5/11/2012 to 5/11/2012.
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. Shanghai Sumier Im's FEI number is 3007830617.
What types of violations has Shanghai Sumier Im received?
Shanghai Sumier Im 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 Shanghai Sumier Im come from?
All FDA import refusal data for Shanghai Sumier Im 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.