DONGGUAN SHIN YI HEALTHCARE PRODUCTS FACTORY
⚠️ Moderate Risk
FEI: 3004829691 • Dongguan, Guangdong • CHINA
FEI Number
3004829691
Location
Dongguan, Guangdong
Country
CHINAAddress
No 17 Banhu, Huang Jiang Town, Dongguan, 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
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).
DEVGMPS
The article appears to be a device for which the methods, facilities, or controls used in, or the facilities or controls used for, its manufacture, packing, storage or installation do not conform to the requirements of Sec. 520(f) and any applicable variance under Sec. 520(f)(2).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/11/2016 | 79KKXDRAPE, SURGICAL | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 1/14/2016 | 79KKXDRAPE, SURGICAL | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 1/8/2016 | 79KKXDRAPE, SURGICAL | 2780DEVICEGMPS | Division of Southwest Imports (DSWI) |
| 1/8/2016 | 79KKXDRAPE, SURGICAL | 2780DEVICEGMPS | Division of Southwest Imports (DSWI) |
| 1/8/2016 | 79KKXDRAPE, SURGICAL | 2780DEVICEGMPS | Division of Southwest Imports (DSWI) |
| 1/7/2016 | 79KKXDRAPE, SURGICAL | 3724DEVGMPS | Southwest Import District Office (SWI-DO) |
| 1/7/2016 | 79KKXDRAPE, SURGICAL | 3724DEVGMPS | Southwest Import District Office (SWI-DO) |
| 12/17/2015 | 79KKXDRAPE, SURGICAL | 3724DEVGMPS | Southwest Import District Office (SWI-DO) |
| 12/17/2015 | 79KKXDRAPE, SURGICAL | 2780DEVICEGMPS | Division of Southwest Imports (DSWI) |
| 12/17/2015 | 79KKXDRAPE, SURGICAL | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 12/17/2015 | 79KKXDRAPE, SURGICAL | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 12/17/2015 | 79KKXDRAPE, SURGICAL | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 12/17/2015 | 79KKXDRAPE, SURGICAL | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 12/17/2015 | 79FYAGOWN, SURGICAL | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 12/17/2015 | 79KKXDRAPE, SURGICAL | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 12/16/2015 | 79KKXDRAPE, SURGICAL | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 12/16/2015 | 79KKXDRAPE, SURGICAL | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 12/16/2015 | 79KKXDRAPE, SURGICAL | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 12/16/2015 | 79KKXDRAPE, SURGICAL | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 12/16/2015 | 79KKXDRAPE, SURGICAL | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 12/16/2015 | 79KKXDRAPE, SURGICAL | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 12/16/2015 | 79KKXDRAPE, SURGICAL | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 12/11/2015 | 79KKXDRAPE, SURGICAL | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 9/29/2010 | 79KKXDRAPE, SURGICAL | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is DONGGUAN SHIN YI HEALTHCARE PRODUCTS FACTORY's FDA import refusal history?
DONGGUAN SHIN YI HEALTHCARE PRODUCTS FACTORY (FEI: 3004829691) has 24 FDA import refusal record(s) in our database, spanning from 9/29/2010 to 2/11/2016.
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. DONGGUAN SHIN YI HEALTHCARE PRODUCTS FACTORY's FEI number is 3004829691.
What types of violations has DONGGUAN SHIN YI HEALTHCARE PRODUCTS FACTORY received?
DONGGUAN SHIN YI HEALTHCARE PRODUCTS FACTORY has been cited for 4 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 DONGGUAN SHIN YI HEALTHCARE PRODUCTS FACTORY come from?
All FDA import refusal data for DONGGUAN SHIN YI HEALTHCARE PRODUCTS 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.