WEIFANG HUAMEI ELECTRONICS CO.,LTD.
⚠️ Moderate Risk
FEI: 3014087237 • Weifang, Shandong • CHINA
FEI Number
3014087237
Location
Weifang, Shandong
Country
CHINAAddress
588 Chang Ning Street, High-Tech District, Weifang, Shandong, 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
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).
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).
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 |
|---|---|---|---|
| 11/20/2019 | 79ONFPOWERED LIGHT BASED NON-LASER SURGICAL INSTRUMENT WITH THERMAL EFFECT | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 9/24/2010 | 79OHTLIGHT BASED OVER-THE-COUNTER HAIR REMOVAL | Cincinnati District Office (CIN-DO) | |
| 3/25/2009 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is WEIFANG HUAMEI ELECTRONICS CO.,LTD.'s FDA import refusal history?
WEIFANG HUAMEI ELECTRONICS CO.,LTD. (FEI: 3014087237) has 3 FDA import refusal record(s) in our database, spanning from 3/25/2009 to 11/20/2019.
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. WEIFANG HUAMEI ELECTRONICS CO.,LTD.'s FEI number is 3014087237.
What types of violations has WEIFANG HUAMEI ELECTRONICS CO.,LTD. received?
WEIFANG HUAMEI ELECTRONICS CO.,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 WEIFANG HUAMEI ELECTRONICS CO.,LTD. come from?
All FDA import refusal data for WEIFANG HUAMEI ELECTRONICS CO.,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.