Ningbo Chinmed Technology Co. Ltd.
⚠️ Moderate Risk
FEI: 3011569598 • Yinzhou • CHINA
FEI Number
3011569598
Location
Yinzhou
Country
CHINAAddress
Hengjie Village Hengjie Town, Ningbo, Yinzhou, , 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
STERILITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.
POSS N/STR
The article appears to consist in whole or in part of any filthy, putrid, or decomposed substance, namely, potentially infectious organisms
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 |
|---|---|---|---|
| 9/10/2020 | 79NADDRESSING, WOUND, OCCLUSIVE | 2800POSS N/STR | Division of West Coast Imports (DWCI) |
| 10/9/2018 | 79NACDRESSING, WOUND, HYDROPHILIC | 508NO 510(K) | Division of West Coast Imports (DWCI) |
| 4/6/2017 | 79NACDRESSING, WOUND, HYDROPHILIC | 78STERILITY | Division of Northeast Imports (DNEI) |
| 1/20/2017 | 79NACDRESSING, WOUND, HYDROPHILIC | 78STERILITY | Division of Northeast Imports (DNEI) |
| 1/20/2017 | 79NACDRESSING, WOUND, HYDROPHILIC | 78STERILITY | Division of Northeast Imports (DNEI) |
| 1/20/2017 | 79NACDRESSING, WOUND, HYDROPHILIC | 78STERILITY | Division of Northeast Imports (DNEI) |
| 1/20/2017 | 79NACDRESSING, WOUND, HYDROPHILIC | 78STERILITY | Division of Northeast Imports (DNEI) |
| 1/20/2017 | 79NACDRESSING, WOUND, HYDROPHILIC | 78STERILITY | Division of Northeast Imports (DNEI) |
| 1/20/2017 | 79NACDRESSING, WOUND, HYDROPHILIC | 78STERILITY | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Ningbo Chinmed Technology Co. Ltd.'s FDA import refusal history?
Ningbo Chinmed Technology Co. Ltd. (FEI: 3011569598) has 9 FDA import refusal record(s) in our database, spanning from 1/20/2017 to 9/10/2020.
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 Chinmed Technology Co. Ltd.'s FEI number is 3011569598.
What types of violations has Ningbo Chinmed Technology Co. Ltd. received?
Ningbo Chinmed Technology 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 Ningbo Chinmed Technology Co. Ltd. come from?
All FDA import refusal data for Ningbo Chinmed 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.