SHENZHEN HUADA SHUN KE ELEC TECH
⚠️ Moderate Risk
FEI: 3012737426 • Shenzhen, Guangdong • CHINA
FEI Number
3012737426
Location
Shenzhen, Guangdong
Country
CHINAAddress
Room 701, Zhongguang Da; Longgang, 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
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).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/31/2018 | 78FCEKIT, ENEMA, (FOR CLEANING PURPOSE) | Division of Northern Border Imports (DNBI) | |
| 1/31/2018 | 85HEDDOUCHE APPARATUS, VAGINAL, THERAPEUTIC | Division of Northern Border Imports (DNBI) | |
| 1/30/2018 | 78FCEKIT, ENEMA, (FOR CLEANING PURPOSE) | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is SHENZHEN HUADA SHUN KE ELEC TECH's FDA import refusal history?
SHENZHEN HUADA SHUN KE ELEC TECH (FEI: 3012737426) has 3 FDA import refusal record(s) in our database, spanning from 1/30/2018 to 1/31/2018.
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 HUADA SHUN KE ELEC TECH's FEI number is 3012737426.
What types of violations has SHENZHEN HUADA SHUN KE ELEC TECH received?
SHENZHEN HUADA SHUN KE ELEC TECH 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 SHENZHEN HUADA SHUN KE ELEC TECH come from?
All FDA import refusal data for SHENZHEN HUADA SHUN KE ELEC TECH 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.