Quasar Electronics (Shenzhen) Co., Ltd
⚠️ Moderate Risk
FEI: 3009560449 • Shenzhen, Guangdong • CHINA
FEI Number
3009560449
Location
Shenzhen, Guangdong
Country
CHINAAddress
Building 8, Phase 1, Baimang, Xili, Shenzhen, 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
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.
DE IMP GMP
The article is subject to refusal of admission pursuant to section 801(a)(1) in that it appears that the methods used in, or the facilities or controls used for, the manufacture of the device do not conform to the applicable requirements of section 520(f).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/10/2012 | 76MMUADHESIVE, DENTURE, ACACIA AND KARAYA WITH SODIUM BORATE > 12% BY WEIGHT | 508NO 510(K) | New York District Office (NYK-DO) |
| 8/10/2012 | 76EEGHEAT SOURCE FOR BLEACHING TEETH | 508NO 510(K) | New York District Office (NYK-DO) |
| 8/10/2012 | 76EEGHEAT SOURCE FOR BLEACHING TEETH | 508NO 510(K) | New York District Office (NYK-DO) |
| 12/9/2011 | 73CCKANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE | 290DE IMP GMP | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Quasar Electronics (Shenzhen) Co., Ltd's FDA import refusal history?
Quasar Electronics (Shenzhen) Co., Ltd (FEI: 3009560449) has 4 FDA import refusal record(s) in our database, spanning from 12/9/2011 to 8/10/2012.
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. Quasar Electronics (Shenzhen) Co., Ltd's FEI number is 3009560449.
What types of violations has Quasar Electronics (Shenzhen) Co., Ltd received?
Quasar Electronics (Shenzhen) 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 Quasar Electronics (Shenzhen) Co., Ltd come from?
All FDA import refusal data for Quasar Electronics (Shenzhen) 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.