Sunstar Guangzhou Ltd.
⚠️ High Risk
FEI: 3009449945 • Guangzhou, Guangdong • CHINA
FEI Number
3009449945
Location
Guangzhou, Guangdong
Country
CHINAAddress
Modern Industry Centre, Blk D F/5; 203 Conbo Avenue, Guangzhou, Guangdong, China
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable 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
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/11/2024 | 53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is Sunstar Guangzhou Ltd.'s FDA import refusal history?
Sunstar Guangzhou Ltd. (FEI: 3009449945) has 1 FDA import refusal record(s) in our database, spanning from 9/11/2024 to 9/11/2024.
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. Sunstar Guangzhou Ltd.'s FEI number is 3009449945.
What types of violations has Sunstar Guangzhou Ltd. received?
Sunstar Guangzhou 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 Sunstar Guangzhou Ltd. come from?
All FDA import refusal data for Sunstar Guangzhou 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.