BEIJING BROAD LASER S&T DEVELOPM
⚠️ Moderate Risk
FEI: 3013366162 • Beijing • CHINA
FEI Number
3013366162
Location
Beijing
Country
CHINAAddress
Biomedical Base, Daxing, , Beijing, , 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).
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
Refusal History
Frequently Asked Questions
What is BEIJING BROAD LASER S&T DEVELOPM's FDA import refusal history?
BEIJING BROAD LASER S&T DEVELOPM (FEI: 3013366162) has 1 FDA import refusal record(s) in our database, spanning from 1/3/2018 to 1/3/2018.
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. BEIJING BROAD LASER S&T DEVELOPM's FEI number is 3013366162.
What types of violations has BEIJING BROAD LASER S&T DEVELOPM received?
BEIJING BROAD LASER S&T DEVELOPM 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 BEIJING BROAD LASER S&T DEVELOPM come from?
All FDA import refusal data for BEIJING BROAD LASER S&T DEVELOPM 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.