Shanghai ChinaStar Corporation
⚠️ Moderate Risk
FEI: 3003849748 • Songjiang District, Shanghai • CHINA
FEI Number
3003849748
Location
Songjiang District, Shanghai
Country
CHINAAddress
283 Che Xing Road, Che Dun Zhen, Songjiang District, 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
HOLES
The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/12/2012 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | New Orleans District Office (NOL-DO) | |
| 10/27/2011 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | New Orleans District Office (NOL-DO) |
| 3/15/2010 | 80NPCGLOVE, PATIENT EXAMINATION, POWDER FREE, | 477HOLES | New York District Office (NYK-DO) |
| 5/4/2009 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Shanghai ChinaStar Corporation's FDA import refusal history?
Shanghai ChinaStar Corporation (FEI: 3003849748) has 4 FDA import refusal record(s) in our database, spanning from 5/4/2009 to 6/12/2012.
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 ChinaStar Corporation's FEI number is 3003849748.
What types of violations has Shanghai ChinaStar Corporation received?
Shanghai ChinaStar Corporation 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 Shanghai ChinaStar Corporation come from?
All FDA import refusal data for Shanghai ChinaStar Corporation 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.