Ningbo Ftz Rivoran Intl Trade Co Ltd
⚠️ Moderate Risk
FEI: 3003385452 • Ningbo • CHINA
FEI Number
3003385452
Location
Ningbo
Country
CHINAAddress
9f Xinjingjiang Bldg No 419 Lingglao Rd, , 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
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 |
|---|---|---|---|
| 12/3/2002 | 79FXXMASK, SURGICAL | 508NO 510(K) | New York District Office (NYK-DO) |
| 12/3/2002 | 79FXXMASK, SURGICAL | 508NO 510(K) | New York District Office (NYK-DO) |
| 12/3/2002 | 79FXXMASK, SURGICAL | 508NO 510(K) | New York District Office (NYK-DO) |
| 12/3/2002 | 79FXXMASK, SURGICAL | 508NO 510(K) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Ningbo Ftz Rivoran Intl Trade Co Ltd's FDA import refusal history?
Ningbo Ftz Rivoran Intl Trade Co Ltd (FEI: 3003385452) has 4 FDA import refusal record(s) in our database, spanning from 12/3/2002 to 12/3/2002.
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 Ftz Rivoran Intl Trade Co Ltd's FEI number is 3003385452.
What types of violations has Ningbo Ftz Rivoran Intl Trade Co Ltd received?
Ningbo Ftz Rivoran Intl Trade 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 Ningbo Ftz Rivoran Intl Trade Co Ltd come from?
All FDA import refusal data for Ningbo Ftz Rivoran Intl Trade 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.