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Yangtze Development Ind Ltd

⚠️ Moderate Risk

FEI: 3005880868 • Shenzhenshenzhen • CHINA

FEI

FEI Number

3005880868

📍

Location

Shenzhenshenzhen

🇨🇳

Country

CHINA
🏢

Address

26f Wenhua Buildshennan East Rd, , Shenzhenshenzhen, , China

Moderate Risk

FDA Import Risk Assessment

37.6
LowModerateHighCritical

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

Statistics

10
Total Refusals
2
Unique Violations
11/14/2008
Latest Refusal
11/14/2008
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
38.6×30%
Recency
0.0×20%
Frequency
100.0×10%
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

11810×

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).

34110×

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
11/14/2008
79GEMGAUZE, ABSORBABLE
118NOT LISTED
341REGISTERED
New England District Office (NWE-DO)
11/14/2008
79GEMGAUZE, ABSORBABLE
118NOT LISTED
341REGISTERED
New England District Office (NWE-DO)
11/14/2008
79GEMGAUZE, ABSORBABLE
118NOT LISTED
341REGISTERED
New England District Office (NWE-DO)
11/14/2008
79GEMGAUZE, ABSORBABLE
118NOT LISTED
341REGISTERED
New England District Office (NWE-DO)
11/14/2008
79GEMGAUZE, ABSORBABLE
118NOT LISTED
341REGISTERED
New England District Office (NWE-DO)
11/14/2008
79GEMGAUZE, ABSORBABLE
118NOT LISTED
341REGISTERED
New England District Office (NWE-DO)
11/14/2008
79GEMGAUZE, ABSORBABLE
118NOT LISTED
341REGISTERED
New England District Office (NWE-DO)
11/14/2008
79GEMGAUZE, ABSORBABLE
118NOT LISTED
341REGISTERED
New England District Office (NWE-DO)
11/14/2008
79GEMGAUZE, ABSORBABLE
118NOT LISTED
341REGISTERED
New England District Office (NWE-DO)
11/14/2008
79GEMGAUZE, ABSORBABLE
118NOT LISTED
341REGISTERED
New England District Office (NWE-DO)

Frequently Asked Questions

What is Yangtze Development Ind Ltd's FDA import refusal history?

Yangtze Development Ind Ltd (FEI: 3005880868) has 10 FDA import refusal record(s) in our database, spanning from 11/14/2008 to 11/14/2008.

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. Yangtze Development Ind Ltd's FEI number is 3005880868.

What types of violations has Yangtze Development Ind Ltd received?

Yangtze Development Ind Ltd 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 Yangtze Development Ind Ltd come from?

All FDA import refusal data for Yangtze Development Ind 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.