SHENZHEN JIA WANG CHANG IMPORT
⚠️ Moderate Risk
FEI: 3016748895 • Shenzhen • CHINA
FEI Number
3016748895
Location
Shenzhen
Country
CHINAAddress
Luohu District Huangbei, , Shenzhen, , 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
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.
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).
DV QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
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 |
|---|---|---|---|
| 1/12/2021 | 80ORWN95 RESPIRATOR WITH ANTIMICROBIAL/ANTIVIRAL AGENT FOR USE BY THE GENERAL PUBLIC IN PUBLIC HEALTH MED | Division of West Coast Imports (DWCI) | |
| 9/23/2020 | 80ORWN95 RESPIRATOR WITH ANTIMICROBIAL/ANTIVIRAL AGENT FOR USE BY THE GENERAL PUBLIC IN PUBLIC HEALTH MED | Division of West Coast Imports (DWCI) | |
| 9/23/2020 | 80ORWN95 RESPIRATOR WITH ANTIMICROBIAL/ANTIVIRAL AGENT FOR USE BY THE GENERAL PUBLIC IN PUBLIC HEALTH MED | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is SHENZHEN JIA WANG CHANG IMPORT's FDA import refusal history?
SHENZHEN JIA WANG CHANG IMPORT (FEI: 3016748895) has 3 FDA import refusal record(s) in our database, spanning from 9/23/2020 to 1/12/2021.
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 JIA WANG CHANG IMPORT's FEI number is 3016748895.
What types of violations has SHENZHEN JIA WANG CHANG IMPORT received?
SHENZHEN JIA WANG CHANG IMPORT has been cited for 5 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 JIA WANG CHANG IMPORT come from?
All FDA import refusal data for SHENZHEN JIA WANG CHANG IMPORT 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.