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Jiangsu Sunshine Import And Export

✅ Low Risk

FEI: 3006158834 • Nanjing, Jiangsu • CHINA

FEI

FEI Number

3006158834

📍

Location

Nanjing, Jiangsu

🇨🇳

Country

CHINA
🏢

Address

Guangzhou Roadrm 1502-1508, 188 Suning Huanqiudasha, Nanjing, Jiangsu, China

Low Risk

FDA Import Risk Assessment

23.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
11/27/2007
Latest Refusal
11/27/2007
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

1182×

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).

3412×

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
11/27/2007
77KCOINHALER, NASAL
118NOT LISTED
341REGISTERED
Los Angeles District Office (LOS-DO)
11/27/2007
77KCOINHALER, NASAL
118NOT LISTED
341REGISTERED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Jiangsu Sunshine Import And Export's FDA import refusal history?

Jiangsu Sunshine Import And Export (FEI: 3006158834) has 2 FDA import refusal record(s) in our database, spanning from 11/27/2007 to 11/27/2007.

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. Jiangsu Sunshine Import And Export's FEI number is 3006158834.

What types of violations has Jiangsu Sunshine Import And Export received?

Jiangsu Sunshine Import And Export has been cited for 2 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 Jiangsu Sunshine Import And Export come from?

All FDA import refusal data for Jiangsu Sunshine Import And Export 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.