SHANDONG DAWEI MEDICAL PRODUCTS CO., LTD.
⚠️ High Risk
FEI: 3012430352 • Weifang, Shandong • CHINA
FEI Number
3012430352
Location
Weifang, Shandong
Country
CHINAAddress
50 Tianshan Huayuan, Qingzhou, Weifang, Shandong, China
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
3905
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 |
|---|---|---|---|
| 1/16/2025 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | Division of Southwest Imports (DSWI) | |
| 1/16/2025 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | Division of Southwest Imports (DSWI) | |
| 1/16/2025 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | Division of Southwest Imports (DSWI) | |
| 1/16/2025 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | Division of Southwest Imports (DSWI) | |
| 1/16/2025 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | Division of Southwest Imports (DSWI) | |
| 1/16/2025 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | Division of Southwest Imports (DSWI) | |
| 1/16/2025 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | Division of Southwest Imports (DSWI) | |
| 1/16/2025 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | Division of Southwest Imports (DSWI) | |
| 1/16/2025 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | Division of Southwest Imports (DSWI) | |
| 1/16/2025 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | Division of Southwest Imports (DSWI) | |
| 1/16/2025 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | Division of Southwest Imports (DSWI) | |
| 1/16/2025 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | Division of Southwest Imports (DSWI) |
Frequently Asked Questions
What is SHANDONG DAWEI MEDICAL PRODUCTS CO., LTD.'s FDA import refusal history?
SHANDONG DAWEI MEDICAL PRODUCTS CO., LTD. (FEI: 3012430352) has 12 FDA import refusal record(s) in our database, spanning from 1/16/2025 to 1/16/2025.
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. SHANDONG DAWEI MEDICAL PRODUCTS CO., LTD.'s FEI number is 3012430352.
What types of violations has SHANDONG DAWEI MEDICAL PRODUCTS CO., LTD. received?
SHANDONG DAWEI MEDICAL PRODUCTS CO., LTD. has been cited for 3 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 SHANDONG DAWEI MEDICAL PRODUCTS CO., LTD. come from?
All FDA import refusal data for SHANDONG DAWEI MEDICAL PRODUCTS 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.