Hainan Kingstar Industrial Co., Ltd.
⚠️ Moderate Risk
FEI: 3007557142 • Guangzhou • CHINA
FEI Number
3007557142
Location
Guangzhou
Country
CHINAAddress
Rm2104, 21/Fl, Suinan Building, No. 63, , Guangzhou, , 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 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
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/6/2009 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | 508NO 510(K) | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Hainan Kingstar Industrial Co., Ltd.'s FDA import refusal history?
Hainan Kingstar Industrial Co., Ltd. (FEI: 3007557142) has 1 FDA import refusal record(s) in our database, spanning from 7/6/2009 to 7/6/2009.
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. Hainan Kingstar Industrial Co., Ltd.'s FEI number is 3007557142.
What types of violations has Hainan Kingstar Industrial Co., Ltd. received?
Hainan Kingstar Industrial Co., Ltd. has been cited for 1 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 Hainan Kingstar Industrial Co., Ltd. come from?
All FDA import refusal data for Hainan Kingstar Industrial 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.