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Nanjing Qingze Medical Technological Development Co., Ltd.

⚠️ Moderate Risk

FEI: 3005067226 • Jiangsu • CHINA

FEI

FEI Number

3005067226

📍

Location

Jiangsu

🇨🇳

Country

CHINA
🏢

Address

8-2-103 Taihe Garden, Zhongyingmen, Road, Xiaguang District, Nanjing,, Jiangsu, China

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
10/24/2008
Latest Refusal
10/24/2008
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
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

751×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
10/24/2008
62BCS99ANTI-HYPERLIPIDEMIC N.E.C.
75UNAPPROVED
Philadelphia District Office (PHI-DO)

Frequently Asked Questions

What is Nanjing Qingze Medical Technological Development Co., Ltd.'s FDA import refusal history?

Nanjing Qingze Medical Technological Development Co., Ltd. (FEI: 3005067226) has 1 FDA import refusal record(s) in our database, spanning from 10/24/2008 to 10/24/2008.

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. Nanjing Qingze Medical Technological Development Co., Ltd.'s FEI number is 3005067226.

What types of violations has Nanjing Qingze Medical Technological Development Co., Ltd. received?

Nanjing Qingze Medical Technological 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 Nanjing Qingze Medical Technological Development Co., Ltd. come from?

All FDA import refusal data for Nanjing Qingze Medical Technological 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.