BEIJING STARLIGHT SCIENCE & TECHNOLOGY DEVELOPM
✅ Low Risk
FEI: 3007113239 • Beijing, Beijing • CHINA
FEI Number
3007113239
Location
Beijing, Beijing
Country
CHINAAddress
No 2 Fuhai Road, Daxing, Beijing, Beijing, China
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
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
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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
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).
RX DEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.
Refusal History
Frequently Asked Questions
What is BEIJING STARLIGHT SCIENCE & TECHNOLOGY DEVELOPM's FDA import refusal history?
BEIJING STARLIGHT SCIENCE & TECHNOLOGY DEVELOPM (FEI: 3007113239) has 1 FDA import refusal record(s) in our database, spanning from 10/16/2012 to 10/16/2012.
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 STARLIGHT SCIENCE & TECHNOLOGY DEVELOPM's FEI number is 3007113239.
What types of violations has BEIJING STARLIGHT SCIENCE & TECHNOLOGY DEVELOPM received?
BEIJING STARLIGHT SCIENCE & TECHNOLOGY DEVELOPM has been cited for 4 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 STARLIGHT SCIENCE & TECHNOLOGY DEVELOPM come from?
All FDA import refusal data for BEIJING STARLIGHT SCIENCE & TECHNOLOGY 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.