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NINGBO CHINMED TECHNOLOGY CO., LTD

⚠️ Moderate Risk

FEI: 3009562494 • Ningbo, Zhejiang • CHINA

FEI

FEI Number

3009562494

📍

Location

Ningbo, Zhejiang

🇨🇳

Country

CHINA
🏢

Address

Shengjiacun, Xiangshan Xian, Ningbo, Zhejiang, China

Moderate Risk

FDA Import Risk Assessment

41.0
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

2
Total Refusals
3
Unique Violations
3/24/2023
Latest Refusal
11/6/2015
Earliest Refusal

Score Breakdown

Violation Severity
66.7×40%
Refusal Volume
17.7×30%
Recency
43.9×20%
Frequency
2.7×10%
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

1181×

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).

3041×

STERILITY

The article appears to consist in whole or in part of any filthy, putrid, or decomposed substance.

32801×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

Refusal History

DateProductViolationsDivision
3/24/2023
79NADDRESSING, WOUND, OCCLUSIVE
118NOT LISTED
3280FRNMFGREG
Division of Southeast Imports (DSEI)
11/6/2015
79NACDRESSING, WOUND, HYDROPHILIC
304STERILITY
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: 3009562494) has 2 FDA import refusal record(s) in our database, spanning from 11/6/2015 to 3/24/2023.

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 3009562494.

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.