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YANGZHOU IAWA BIOSCIENCE DEVELOPMENT CO., LTD.

⚠️ Moderate Risk

FEI: 3006121479 • Yangzhou, Jiangsu • CHINA

FEI

FEI Number

3006121479

📍

Location

Yangzhou, Jiangsu

🇨🇳

Country

CHINA
🏢

Address

Hanjiang Ind. Park, 211 Jian Road; Hanjiang, Yangzhou, Jiangsu, China

Moderate Risk

FDA Import Risk Assessment

29.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
11/2/2011
Latest Refusal
11/2/2011
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

1183×

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).

Refusal History

DateProductViolationsDivision
11/2/2011
73BTRTUBE, TRACHEAL (W/WO CONNECTOR)
118NOT LISTED
Atlanta District Office (ATL-DO)
11/2/2011
73BTRTUBE, TRACHEAL (W/WO CONNECTOR)
118NOT LISTED
Atlanta District Office (ATL-DO)
11/2/2011
73BTRTUBE, TRACHEAL (W/WO CONNECTOR)
118NOT LISTED
Atlanta District Office (ATL-DO)

Frequently Asked Questions

What is YANGZHOU IAWA BIOSCIENCE DEVELOPMENT CO., LTD.'s FDA import refusal history?

YANGZHOU IAWA BIOSCIENCE DEVELOPMENT CO., LTD. (FEI: 3006121479) has 3 FDA import refusal record(s) in our database, spanning from 11/2/2011 to 11/2/2011.

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. YANGZHOU IAWA BIOSCIENCE DEVELOPMENT CO., LTD.'s FEI number is 3006121479.

What types of violations has YANGZHOU IAWA BIOSCIENCE DEVELOPMENT CO., LTD. received?

YANGZHOU IAWA BIOSCIENCE DEVELOPMENT 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 YANGZHOU IAWA BIOSCIENCE DEVELOPMENT CO., LTD. come from?

All FDA import refusal data for YANGZHOU IAWA BIOSCIENCE DEVELOPMENT 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.