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Ningbo Sunda Intl Co Ltd

✅ Low Risk

FEI: 3011718545 • Ningbo • CHINA

FEI

FEI Number

3011718545

📍

Location

Ningbo

🇨🇳

Country

CHINA
🏢

Address

Rm 210, NO 14 Bldg 1188 Zhongguan, Ningbo, , China

Low Risk

FDA Import Risk Assessment

16.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
1
Unique Violations
10/16/2015
Latest Refusal
10/16/2015
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
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
10/16/2015
77JPWPUMP, NEBULIZER, ELECTRICALLY POWERED
341REGISTERED
San Francisco District Office (SAN-DO)

Frequently Asked Questions

What is Ningbo Sunda Intl Co Ltd's FDA import refusal history?

Ningbo Sunda Intl Co Ltd (FEI: 3011718545) has 1 FDA import refusal record(s) in our database, spanning from 10/16/2015 to 10/16/2015.

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 Sunda Intl Co Ltd's FEI number is 3011718545.

What types of violations has Ningbo Sunda Intl Co Ltd received?

Ningbo Sunda Intl 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 Sunda Intl Co Ltd come from?

All FDA import refusal data for Ningbo Sunda Intl 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.