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NINGBO VERYKIND MEDICAL DEVICE CO LTD

⚠️ Moderate Risk

FEI: 3021604067 • Ningbo, Zhejiang • CHINA

FEI

FEI Number

3021604067

📍

Location

Ningbo, Zhejiang

🇨🇳

Country

CHINA
🏢

Address

# 100, Jinghua Road, High-Tech; Industrial Development Zone, Ningbo, Zhejiang, China

Moderate Risk

FDA Import Risk Assessment

26.7
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
8/21/2023
Latest Refusal
8/21/2023
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
Refusal Volume
11.2×30%
Recency
51.6×20%
Frequency
10.0×10%
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

3411×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

Refusal History

DateProductViolationsDivision
8/21/2023
79GDWSTAPLE, IMPLANTABLE
341REGISTERED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is NINGBO VERYKIND MEDICAL DEVICE CO LTD's FDA import refusal history?

NINGBO VERYKIND MEDICAL DEVICE CO LTD (FEI: 3021604067) has 1 FDA import refusal record(s) in our database, spanning from 8/21/2023 to 8/21/2023.

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 VERYKIND MEDICAL DEVICE CO LTD's FEI number is 3021604067.

What types of violations has NINGBO VERYKIND MEDICAL DEVICE CO LTD received?

NINGBO VERYKIND MEDICAL DEVICE 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 VERYKIND MEDICAL DEVICE CO LTD come from?

All FDA import refusal data for NINGBO VERYKIND MEDICAL DEVICE 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.