Shanghai Jiu Mao Foreign Trade
⚠️ Moderate Risk
FEI: 3003627862 • Shanghai, Shanghai • CHINA
FEI Number
3003627862
Location
Shanghai, Shanghai
Country
CHINAAddress
Xinda Building F/21, 322 Xianxialu, 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
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.
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).
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
NO PMA/PDP
The article appears to be a class III dev.w/o an approved applic. for premarket approval, and/or a notice of completion of product development protocol filed per section 515(b) or exempt per sect.520(g)(1).
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 |
|---|---|---|---|
| 10/2/2003 | 83JRHINCUBATOR/WATER BATH, FOR CLINICAL USE | Florida District Office (FLA-DO) | |
| 9/26/2003 | 73KLKMONITOR, OXYGEN, CUTANEOUS, FOR INFANT NOT UNDER GAS ANESTHESIA | Florida District Office (FLA-DO) | |
| 9/8/2003 | 80LDQDEVICE, GENERAL MEDICAL | Florida District Office (FLA-DO) | |
| 5/27/2003 | 79MDWINSTRUMENT, MANUAL, SURGICAL, GENERAL USE | Florida District Office (FLA-DO) | |
| 3/7/2003 | 83JRHINCUBATOR/WATER BATH, FOR CLINICAL USE | Division of Southeast Imports (DSEI) | |
| 10/16/2002 | 75LXGEQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE | 118NOT LISTED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Shanghai Jiu Mao Foreign Trade's FDA import refusal history?
Shanghai Jiu Mao Foreign Trade (FEI: 3003627862) has 6 FDA import refusal record(s) in our database, spanning from 10/16/2002 to 10/2/2003.
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 Jiu Mao Foreign Trade's FEI number is 3003627862.
What types of violations has Shanghai Jiu Mao Foreign Trade received?
Shanghai Jiu Mao Foreign Trade has been cited for 5 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 Jiu Mao Foreign Trade come from?
All FDA import refusal data for Shanghai Jiu Mao Foreign Trade 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.