NINGBO DASKY LIFE SCIENCE CO., LTD.
⚠️ Moderate Risk
FEI: 3017230771 • Ningbo, Zhejiang • CHINA
FEI Number
3017230771
Location
Ningbo, Zhejiang
Country
CHINAAddress
No. 6 Donggong 1st Road, Yinzhou District, 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
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 |
|---|---|---|---|
| 5/5/2021 | 80FMHCONTAINER, SPECIMEN | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 5/5/2021 | 80FMHCONTAINER, SPECIMEN | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 5/5/2021 | 80FMHCONTAINER, SPECIMEN | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 5/5/2021 | 80FMFSYRINGE, PISTON | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 3/19/2021 | 80KXFAPPLICATOR, ABSORBENT TIPPED, NON-STERILE | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 3/19/2021 | 80KXFAPPLICATOR, ABSORBENT TIPPED, NON-STERILE | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 3/19/2021 | 80KXFAPPLICATOR, ABSORBENT TIPPED, NON-STERILE | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 3/19/2021 | 80KXFAPPLICATOR, ABSORBENT TIPPED, NON-STERILE | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 3/19/2021 | 80KXFAPPLICATOR, ABSORBENT TIPPED, NON-STERILE | 508NO 510(K) | Division of Southwest Imports (DSWI) |
Frequently Asked Questions
What is NINGBO DASKY LIFE SCIENCE CO., LTD.'s FDA import refusal history?
NINGBO DASKY LIFE SCIENCE CO., LTD. (FEI: 3017230771) has 9 FDA import refusal record(s) in our database, spanning from 3/19/2021 to 5/5/2021.
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 DASKY LIFE SCIENCE CO., LTD.'s FEI number is 3017230771.
What types of violations has NINGBO DASKY LIFE SCIENCE CO., LTD. received?
NINGBO DASKY LIFE SCIENCE 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 DASKY LIFE SCIENCE CO., LTD. come from?
All FDA import refusal data for NINGBO DASKY LIFE SCIENCE 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.