Yangzhou Shuguang Toothbrushe Ma
⚠️ Moderate Risk
FEI: 3007577668 • Yangzhou, Jiangsu • CHINA
FEI Number
3007577668
Location
Yangzhou, Jiangsu
Country
CHINAAddress
40 Weiyelu, Hanjiang, Yangzhou, Jiangsu, 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
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).
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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 |
|---|---|---|---|
| 10/21/2015 | 76EFWTOOTHBRUSH, MANUAL | Division of Northeast Imports (DNEI) | |
| 1/28/2010 | 83LOPSOLUTION, ANTIMICROBIAL | 16DIRECTIONS | Seattle District Office (SEA-DO) |
| 12/30/2009 | 80FLKTHERMOMETER, CLINICAL MERCURY | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Yangzhou Shuguang Toothbrushe Ma's FDA import refusal history?
Yangzhou Shuguang Toothbrushe Ma (FEI: 3007577668) has 3 FDA import refusal record(s) in our database, spanning from 12/30/2009 to 10/21/2015.
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. Yangzhou Shuguang Toothbrushe Ma's FEI number is 3007577668.
What types of violations has Yangzhou Shuguang Toothbrushe Ma received?
Yangzhou Shuguang Toothbrushe Ma 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 Yangzhou Shuguang Toothbrushe Ma come from?
All FDA import refusal data for Yangzhou Shuguang Toothbrushe Ma 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.