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Zhenjiang International Economic-Technical Cooperation Corp.

⚠️ Moderate Risk

FEI: 1000573013 • Zhenjiang, Jiangsu • CHINA

FEI

FEI Number

1000573013

📍

Location

Zhenjiang, Jiangsu

🇨🇳

Country

CHINA
🏢

Address

40 Jiankanglu, , Zhenjiang, Jiangsu, China

Moderate Risk

FDA Import Risk Assessment

27.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
4/8/2011
Latest Refusal
2/23/2011
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
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

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).

841×

RX DEVICE

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.

Refusal History

DateProductViolationsDivision
4/8/2011
86MVNLENS, CONTACT (DISPOSABLE)
341REGISTERED
New York District Office (NYK-DO)
2/23/2011
89LZXACID, SODIUM HYALURONIC, INTRA-ARTICULAR
84RX DEVICE
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Zhenjiang International Economic-Technical Cooperation Corp.'s FDA import refusal history?

Zhenjiang International Economic-Technical Cooperation Corp. (FEI: 1000573013) has 2 FDA import refusal record(s) in our database, spanning from 2/23/2011 to 4/8/2011.

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. Zhenjiang International Economic-Technical Cooperation Corp.'s FEI number is 1000573013.

What types of violations has Zhenjiang International Economic-Technical Cooperation Corp. received?

Zhenjiang International Economic-Technical Cooperation Corp. 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 Zhenjiang International Economic-Technical Cooperation Corp. come from?

All FDA import refusal data for Zhenjiang International Economic-Technical Cooperation Corp. 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.