Rossmax (Shanghai) Inc., Ltd.
⚠️ Moderate Risk
FEI: 3004003272 • Shanghai, Shanghai • CHINA
FEI Number
3004003272
Location
Shanghai, Shanghai
Country
CHINAAddress
No. 6018 Huyi Highway, Jiading, 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
DEVICEGMPS
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.
DE IMP GMP
The article is subject to refusal of admission pursuant to section 801(a)(1) in that it appears that the methods used in, or the facilities or controls used for, the manufacture of the device do not conform to the applicable requirements of section 520(f).
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 |
|---|---|---|---|
| 9/16/2011 | 74OFECENTRAL VENOUS BLOOD PRESSURE KIT | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 2/25/2010 | 74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 2/25/2010 | 74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 9/17/2008 | 74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | 2780DEVICEGMPS | Chicago District Office (CHI-DO) |
| 8/27/2008 | 74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 7/7/2008 | 74DXQCUFF, BLOOD-PRESSURE | 2780DEVICEGMPS | Chicago District Office (CHI-DO) |
| 7/7/2008 | 74DXQCUFF, BLOOD-PRESSURE | 2780DEVICEGMPS | Chicago District Office (CHI-DO) |
| 3/9/2006 | 80LMYMONITOR, SKIN RESISTANCE/SKIN TEMPERATURE, FOR INSULIN REACTIONS | 341REGISTERED | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Rossmax (Shanghai) Inc., Ltd.'s FDA import refusal history?
Rossmax (Shanghai) Inc., Ltd. (FEI: 3004003272) has 8 FDA import refusal record(s) in our database, spanning from 3/9/2006 to 9/16/2011.
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. Rossmax (Shanghai) Inc., Ltd.'s FEI number is 3004003272.
What types of violations has Rossmax (Shanghai) Inc., Ltd. received?
Rossmax (Shanghai) Inc., Ltd. has been cited for 3 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 Rossmax (Shanghai) Inc., Ltd. come from?
All FDA import refusal data for Rossmax (Shanghai) Inc., 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.