Shanghai Sofine International Trade Co., Ltd.
⚠️ Moderate Risk
FEI: 3006681542 • Shanghai, Shanghai • CHINA
FEI Number
3006681542
Location
Shanghai, Shanghai
Country
CHINAAddress
1602, 21 Changyi Road, Shanghai, Shanghai, 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).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/21/2009 | 80FLKTHERMOMETER, CLINICAL MERCURY | Los Angeles District Office (LOS-DO) | |
| 12/21/2009 | 74OEDANTIMICROBIAL BLOOD PRESSURE CUFF | Los Angeles District Office (LOS-DO) | |
| 12/21/2009 | 74OEDANTIMICROBIAL BLOOD PRESSURE CUFF | Los Angeles District Office (LOS-DO) | |
| 12/21/2009 | 74LDESTETHOSCOPE, MANUAL | 341REGISTERED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Shanghai Sofine International Trade Co., Ltd.'s FDA import refusal history?
Shanghai Sofine International Trade Co., Ltd. (FEI: 3006681542) has 4 FDA import refusal record(s) in our database, spanning from 12/21/2009 to 12/21/2009.
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 Sofine International Trade Co., Ltd.'s FEI number is 3006681542.
What types of violations has Shanghai Sofine International Trade Co., Ltd. received?
Shanghai Sofine International Trade 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 Sofine International Trade Co., Ltd. come from?
All FDA import refusal data for Shanghai Sofine International Trade 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.