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Beijing Zizhu Tiangong Science & Technology Co. Ltd.

⚠️ Moderate Risk

FEI: 3011275458 • Beijing, Beijing • CHINA

FEI

FEI Number

3011275458

📍

Location

Beijing, Beijing

🇨🇳

Country

CHINA
🏢

Address

No. 27 Chaoyang North Road, Chaoyang District, Beijing, Beijing, China

Moderate Risk

FDA Import Risk Assessment

28.6
LowModerateHighCritical

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

Statistics

2
Total Refusals
3
Unique Violations
9/2/2015
Latest Refusal
9/2/2015
Earliest Refusal

Score Breakdown

Violation Severity
53.3×40%
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

1182×

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).

2232×

FALSE

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.

32802×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

Refusal History

DateProductViolationsDivision
9/2/2015
64GCT18ESTRONE (ESTROGEN)
118NOT LISTED
223FALSE
3280FRNMFGREG
Seattle District Office (SEA-DO)
9/2/2015
64GCT18ESTRONE (ESTROGEN)
118NOT LISTED
223FALSE
3280FRNMFGREG
Seattle District Office (SEA-DO)

Frequently Asked Questions

What is Beijing Zizhu Tiangong Science & Technology Co. Ltd.'s FDA import refusal history?

Beijing Zizhu Tiangong Science & Technology Co. Ltd. (FEI: 3011275458) has 2 FDA import refusal record(s) in our database, spanning from 9/2/2015 to 9/2/2015.

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. Beijing Zizhu Tiangong Science & Technology Co. Ltd.'s FEI number is 3011275458.

What types of violations has Beijing Zizhu Tiangong Science & Technology Co. Ltd. received?

Beijing Zizhu Tiangong Science & Technology Co. Ltd. has been cited for 3 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 Beijing Zizhu Tiangong Science & Technology Co. Ltd. come from?

All FDA import refusal data for Beijing Zizhu Tiangong Science & Technology 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.