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GUANGDONG ZHIZHEN BIOLOGICAL MED

⚠️ Moderate Risk

FEI: 3016741071 • Shenzhen • CHINA

FEI

FEI Number

3016741071

📍

Location

Shenzhen

🇨🇳

Country

CHINA
🏢

Address

No 309 Zhongzheng Fortu, , Shenzhen, , China

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
6/18/2020
Latest Refusal
6/18/2020
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

4791×

DV QUALITY

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.

Refusal History

DateProductViolationsDivision
6/18/2020
80MSHRESPIRATOR, SURGICAL
479DV QUALITY
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is GUANGDONG ZHIZHEN BIOLOGICAL MED's FDA import refusal history?

GUANGDONG ZHIZHEN BIOLOGICAL MED (FEI: 3016741071) has 1 FDA import refusal record(s) in our database, spanning from 6/18/2020 to 6/18/2020.

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. GUANGDONG ZHIZHEN BIOLOGICAL MED's FEI number is 3016741071.

What types of violations has GUANGDONG ZHIZHEN BIOLOGICAL MED received?

GUANGDONG ZHIZHEN BIOLOGICAL MED 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 GUANGDONG ZHIZHEN BIOLOGICAL MED come from?

All FDA import refusal data for GUANGDONG ZHIZHEN BIOLOGICAL MED 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.