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Qinhuangdao Zizhu Pharmaceutical, Co.

⚠️ Moderate Risk

FEI: 3009653722 • Qinhuangdao, Hebei • CHINA

FEI

FEI Number

3009653722

📍

Location

Qinhuangdao, Hebei

🇨🇳

Country

CHINA
🏢

Address

Economic & Technological Development Zon, No 10 Longhai Avenue; Haigang, Qinhuangdao, Hebei, 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
5/23/2014
Latest Refusal
5/23/2014
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

161×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

Refusal History

DateProductViolationsDivision
5/23/2014
60NIL14TESTOSTERONE (ANDROGEN)
16DIRECTIONS
Seattle District Office (SEA-DO)

Frequently Asked Questions

What is Qinhuangdao Zizhu Pharmaceutical, Co.'s FDA import refusal history?

Qinhuangdao Zizhu Pharmaceutical, Co. (FEI: 3009653722) has 1 FDA import refusal record(s) in our database, spanning from 5/23/2014 to 5/23/2014.

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. Qinhuangdao Zizhu Pharmaceutical, Co.'s FEI number is 3009653722.

What types of violations has Qinhuangdao Zizhu Pharmaceutical, Co. received?

Qinhuangdao Zizhu Pharmaceutical, Co. 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 Qinhuangdao Zizhu Pharmaceutical, Co. come from?

All FDA import refusal data for Qinhuangdao Zizhu Pharmaceutical, Co. 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.