Mianyang Sonic Electronic Ltd
⚠️ Moderate Risk
FEI: 3004117697 • Sichuan Province • CHINA
FEI Number
3004117697
Location
Sichuan Province
Country
CHINAAddress
18 Xingsheng Street Changhong Blvd, , Sichuan Province, , 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
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/31/2009 | 79NRJULTRASOUND, SKIN PERMEATION | Florida District Office (FLA-DO) | |
| 7/28/2004 | 79LFLINSTRUMENT, ULTRASONIC SURGICAL | Division of Southeast Imports (DSEI) | |
| 9/22/2003 | 80FLGCLEANER, ULTRASONIC, MEDICAL INSTRUMENT | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Mianyang Sonic Electronic Ltd's FDA import refusal history?
Mianyang Sonic Electronic Ltd (FEI: 3004117697) has 3 FDA import refusal record(s) in our database, spanning from 9/22/2003 to 12/31/2009.
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. Mianyang Sonic Electronic Ltd's FEI number is 3004117697.
What types of violations has Mianyang Sonic Electronic Ltd received?
Mianyang Sonic Electronic 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 Mianyang Sonic Electronic Ltd come from?
All FDA import refusal data for Mianyang Sonic Electronic 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.