Zhang Kei Elecronic Co
⚠️ Moderate Risk
FEI: 3010363964 • 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
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/3/2013 | 78JCWPROSTHESIS, PENIS, INFLATABLE | 16DIRECTIONS | Los Angeles District Office (LOS-DO) |
| 10/3/2013 | 78JCWPROSTHESIS, PENIS, INFLATABLE | 16DIRECTIONS | Los Angeles District Office (LOS-DO) |
| 10/3/2013 | 78JCWPROSTHESIS, PENIS, INFLATABLE | 16DIRECTIONS | Los Angeles District Office (LOS-DO) |
| 10/3/2013 | 78JCWPROSTHESIS, PENIS, INFLATABLE | 16DIRECTIONS | Los Angeles District Office (LOS-DO) |
| 10/3/2013 | 78JCWPROSTHESIS, PENIS, INFLATABLE | 16DIRECTIONS | Los Angeles District Office (LOS-DO) |
| 10/3/2013 | 78JCWPROSTHESIS, PENIS, INFLATABLE | 16DIRECTIONS | Los Angeles District Office (LOS-DO) |
| 10/3/2013 | 78JCWPROSTHESIS, PENIS, INFLATABLE | 16DIRECTIONS | Los Angeles District Office (LOS-DO) |
| 10/3/2013 | 78JCWPROSTHESIS, PENIS, INFLATABLE | 16DIRECTIONS | Los Angeles District Office (LOS-DO) |
| 10/3/2013 | 78JCWPROSTHESIS, PENIS, INFLATABLE | 16DIRECTIONS | Los Angeles District Office (LOS-DO) |
| 10/3/2013 | 78JCWPROSTHESIS, PENIS, INFLATABLE | 16DIRECTIONS | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Zhang Kei Elecronic Co's FDA import refusal history?
Zhang Kei Elecronic Co (FEI: 3010363964) has 10 FDA import refusal record(s) in our database, spanning from 10/3/2013 to 10/3/2013.
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. Zhang Kei Elecronic Co's FEI number is 3010363964.
What types of violations has Zhang Kei Elecronic Co received?
Zhang Kei Elecronic Co 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 Zhang Kei Elecronic Co come from?
All FDA import refusal data for Zhang Kei Elecronic Co 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.