SUZHOU MASTER LASER CO., LTD.
⚠️ Moderate Risk
FEI: 3015217864 • Daxin Town • CHINA
FEI Number
3015217864
Location
Daxin Town
Country
CHINAAddress
# 4f Block Ano 8. Xinchu, , Daxin Town, , 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
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.
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
Refusal History
Frequently Asked Questions
What is SUZHOU MASTER LASER CO., LTD.'s FDA import refusal history?
SUZHOU MASTER LASER CO., LTD. (FEI: 3015217864) has 1 FDA import refusal record(s) in our database, spanning from 5/24/2019 to 5/24/2019.
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. SUZHOU MASTER LASER CO., LTD.'s FEI number is 3015217864.
What types of violations has SUZHOU MASTER LASER CO., LTD. received?
SUZHOU MASTER LASER 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 SUZHOU MASTER LASER CO., LTD. come from?
All FDA import refusal data for SUZHOU MASTER LASER 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.