SHANGHAI ZOGEAR INDUSTRIES CO., LTD.
⚠️ Moderate Risk
FEI: 3010583458 • Shanghai, Shanghai • CHINA
FEI Number
3010583458
Location
Shanghai, Shanghai
Country
CHINAAddress
Building 3 Suite 303, 406 Kangyilu, Shanghai, Shanghai, 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
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 |
|---|---|---|---|
| 7/5/2016 | 76JETPICK, MASSAGING | 341REGISTERED | San Francisco District Office (SAN-DO) |
| 7/5/2016 | 76EHRPAD, DENTURE, OTC | 341REGISTERED | San Francisco District Office (SAN-DO) |
| 7/5/2016 | 76EHRPAD, DENTURE, OTC | 341REGISTERED | San Francisco District Office (SAN-DO) |
| 7/5/2016 | 76EHRPAD, DENTURE, OTC | 341REGISTERED | San Francisco District Office (SAN-DO) |
| 7/5/2016 | 76ELWMATERIAL, IMPRESSION | 341REGISTERED | San Francisco District Office (SAN-DO) |
| 7/5/2016 | 76EHRPAD, DENTURE, OTC | 341REGISTERED | San Francisco District Office (SAN-DO) |
| 7/5/2016 | 76EFNCOTTON, ROLL | 341REGISTERED | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is SHANGHAI ZOGEAR INDUSTRIES CO., LTD.'s FDA import refusal history?
SHANGHAI ZOGEAR INDUSTRIES CO., LTD. (FEI: 3010583458) has 7 FDA import refusal record(s) in our database, spanning from 7/5/2016 to 7/5/2016.
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. SHANGHAI ZOGEAR INDUSTRIES CO., LTD.'s FEI number is 3010583458.
What types of violations has SHANGHAI ZOGEAR INDUSTRIES CO., LTD. received?
SHANGHAI ZOGEAR INDUSTRIES 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 SHANGHAI ZOGEAR INDUSTRIES CO., LTD. come from?
All FDA import refusal data for SHANGHAI ZOGEAR INDUSTRIES 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.