ImportRefusal LogoImportRefusal

Anbru Scientech Co., LTD.

⚠️ Moderate Risk

FEI: 3008268652 • Nanjing, Jiangsu • CHINA

FEI

FEI Number

3008268652

📍

Location

Nanjing, Jiangsu

🇨🇳

Country

CHINA
🏢

Address

Jiangsu International Trade Bldg 3102, 50 Zhong Hua Road; Qinhuai, Nanjing, Jiangsu, China

Moderate Risk

FDA Import Risk Assessment

35.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
2/27/2009
Latest Refusal
2/23/2009
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

162×

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
2/27/2009
64GAR99ESTROGEN N.E.C.
16DIRECTIONS
New York District Office (NYK-DO)
2/23/2009
64GIY99ESTROGEN N.E.C.
16DIRECTIONS
New York District Office (NYK-DO)

Frequently Asked Questions

What is Anbru Scientech Co., LTD.'s FDA import refusal history?

Anbru Scientech Co., LTD. (FEI: 3008268652) has 2 FDA import refusal record(s) in our database, spanning from 2/23/2009 to 2/27/2009.

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. Anbru Scientech Co., LTD.'s FEI number is 3008268652.

What types of violations has Anbru Scientech Co., LTD. received?

Anbru Scientech 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 Anbru Scientech Co., LTD. come from?

All FDA import refusal data for Anbru Scientech 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.