BROAD CLEAN AIR TECHNOLOGY CO., LTD.
⚠️ Moderate Risk
FEI: 3016821211 • Changsha, Hunan • CHINA
FEI Number
3016821211
Location
Changsha, Hunan
Country
CHINAAddress
No. 6 Yuan Da Second Road, Xingshazhen Changshaxian, Changsha, Hunan, 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 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
Frequently Asked Questions
What is BROAD CLEAN AIR TECHNOLOGY CO., LTD.'s FDA import refusal history?
BROAD CLEAN AIR TECHNOLOGY CO., LTD. (FEI: 3016821211) has 1 FDA import refusal record(s) in our database, spanning from 11/6/2020 to 11/6/2020.
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. BROAD CLEAN AIR TECHNOLOGY CO., LTD.'s FEI number is 3016821211.
What types of violations has BROAD CLEAN AIR TECHNOLOGY CO., LTD. received?
BROAD CLEAN AIR TECHNOLOGY CO., LTD. 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 BROAD CLEAN AIR TECHNOLOGY CO., LTD. come from?
All FDA import refusal data for BROAD CLEAN AIR TECHNOLOGY 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.