NINGBO YIXIN INTELLINGENTIZED SCIENCE AND TECHNOLOGY CO., LTD
⚠️ Moderate Risk
FEI: 3016700549 • Ningbo, Zhejiang • CHINA
FEI Number
3016700549
Location
Ningbo, Zhejiang
Country
CHINAAddress
No. 26 Shangqiao Road, Xiwu Science Park, Fenghua, , Ningbo, Zhejiang, 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
DV QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
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 |
|---|---|---|---|
| 1/8/2022 | 80QKRFACE MASK (EXCEPT N95 RESPIRATOR) FOR GENERAL PUBLIC/HEALTHCARE PERSONNEL PER IIE GUIDANCE | 479DV QUALITY | Division of West Coast Imports (DWCI) |
| 9/22/2020 | 80NZJRESPIRATOR, N95, HOME USE | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 8/28/2020 | 80QKRFACE MASK (EXCEPT N95 RESPIRATOR) FOR GENERAL PUBLIC/HEALTHCARE PERSONNEL PER IIE GUIDANCE | 479DV QUALITY | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is NINGBO YIXIN INTELLINGENTIZED SCIENCE AND TECHNOLOGY CO., LTD's FDA import refusal history?
NINGBO YIXIN INTELLINGENTIZED SCIENCE AND TECHNOLOGY CO., LTD (FEI: 3016700549) has 3 FDA import refusal record(s) in our database, spanning from 8/28/2020 to 1/8/2022.
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 YIXIN INTELLINGENTIZED SCIENCE AND TECHNOLOGY CO., LTD's FEI number is 3016700549.
What types of violations has NINGBO YIXIN INTELLINGENTIZED SCIENCE AND TECHNOLOGY CO., LTD received?
NINGBO YIXIN INTELLINGENTIZED SCIENCE AND TECHNOLOGY 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 YIXIN INTELLINGENTIZED SCIENCE AND TECHNOLOGY CO., LTD come from?
All FDA import refusal data for NINGBO YIXIN INTELLINGENTIZED SCIENCE AND TECHNOLOGY 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.