GUANGZHOU BAOWEIKANG LABOR PROTE
⚠️ Moderate Risk
FEI: 3017145680 • Guangzhou • CHINA
FEI Number
3017145680
Location
Guangzhou
Country
CHINAAddress
Baoweikang Ind Pk, 43 T, , Guangzhou, , 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
NIOSH-EUA
The respirator is from a lot or shipment that failed testing and, pursuant to a condition of the applicable emergency use authorization (EUA), cannot be distributed.
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
Frequently Asked Questions
What is GUANGZHOU BAOWEIKANG LABOR PROTE's FDA import refusal history?
GUANGZHOU BAOWEIKANG LABOR PROTE (FEI: 3017145680) has 1 FDA import refusal record(s) in our database, spanning from 9/18/2020 to 9/18/2020.
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. GUANGZHOU BAOWEIKANG LABOR PROTE's FEI number is 3017145680.
What types of violations has GUANGZHOU BAOWEIKANG LABOR PROTE received?
GUANGZHOU BAOWEIKANG LABOR PROTE has been cited for 2 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 GUANGZHOU BAOWEIKANG LABOR PROTE come from?
All FDA import refusal data for GUANGZHOU BAOWEIKANG LABOR PROTE 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.