Ningbo Yutai International Co Ltd
⚠️ Moderate Risk
FEI: 3004491431 • Ningbo • CHINA
FEI Number
3004491431
Location
Ningbo
Country
CHINAAddress
Ningbo Free Trade Zone Room 836, , Ningbo, , 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).
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 |
|---|---|---|---|
| 4/19/2004 | 78FJCDETECTOR, BLOOD LEVEL | Florida District Office (FLA-DO) | |
| 4/19/2004 | 76EBALIGHT, SURGICAL HEADLIGHT | Florida District Office (FLA-DO) | |
| 4/19/2004 | 76EBALIGHT, SURGICAL HEADLIGHT | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Ningbo Yutai International Co Ltd's FDA import refusal history?
Ningbo Yutai International Co Ltd (FEI: 3004491431) has 3 FDA import refusal record(s) in our database, spanning from 4/19/2004 to 4/19/2004.
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. Ningbo Yutai International Co Ltd's FEI number is 3004491431.
What types of violations has Ningbo Yutai International Co Ltd received?
Ningbo Yutai International 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 Ningbo Yutai International Co Ltd come from?
All FDA import refusal data for Ningbo Yutai International 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.