Shenzhen Baoan Xixiang Item Plastic And Metal Factory
⚠️ Moderate Risk
FEI: 3008057028 • Shenzhen, Guangdong • CHINA
FEI Number
3008057028
Location
Shenzhen, Guangdong
Country
CHINAAddress
Xinxing Guangchang, Ma Ti Tang, Gu Shu, Guang Shen Road, Shenzhen, Guangdong, 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
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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).
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
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 |
|---|---|---|---|
| 3/24/2015 | 76JEQTOOTHBRUSH, POWERED | Cincinnati District Office (CIN-DO) | |
| 3/16/2015 | 76JEQTOOTHBRUSH, POWERED | Seattle District Office (SEA-DO) | |
| 3/16/2015 | 76JEQTOOTHBRUSH, POWERED | Division of Southeast Imports (DSEI) | |
| 8/27/2014 | 76JEQTOOTHBRUSH, POWERED | 341REGISTERED | New York District Office (NYK-DO) |
| 9/18/2013 | 74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Shenzhen Baoan Xixiang Item Plastic And Metal Factory's FDA import refusal history?
Shenzhen Baoan Xixiang Item Plastic And Metal Factory (FEI: 3008057028) has 5 FDA import refusal record(s) in our database, spanning from 9/18/2013 to 3/24/2015.
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. Shenzhen Baoan Xixiang Item Plastic And Metal Factory's FEI number is 3008057028.
What types of violations has Shenzhen Baoan Xixiang Item Plastic And Metal Factory received?
Shenzhen Baoan Xixiang Item Plastic And Metal Factory 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 Shenzhen Baoan Xixiang Item Plastic And Metal Factory come from?
All FDA import refusal data for Shenzhen Baoan Xixiang Item Plastic And Metal Factory 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.