Stareast Beauty & Health Mfg
⚠️ Moderate Risk
FEI: 3008880361 • Guangdong • CHINA
FEI Number
3008880361
Location
Guangdong
Country
CHINAAddress
No 9 Bixi Road Daliang, , Guangdong, , 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).
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.
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.
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/4/2012 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | New Orleans District Office (NOL-DO) | |
| 5/27/2011 | 79ONFPOWERED LIGHT BASED NON-LASER SURGICAL INSTRUMENT WITH THERMAL EFFECT | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Stareast Beauty & Health Mfg's FDA import refusal history?
Stareast Beauty & Health Mfg (FEI: 3008880361) has 2 FDA import refusal record(s) in our database, spanning from 5/27/2011 to 6/4/2012.
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. Stareast Beauty & Health Mfg's FEI number is 3008880361.
What types of violations has Stareast Beauty & Health Mfg received?
Stareast Beauty & Health Mfg has been cited for 5 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 Stareast Beauty & Health Mfg come from?
All FDA import refusal data for Stareast Beauty & Health Mfg 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.