ImportRefusal LogoImportRefusal

Shanghai Desano Bio-Pharmaceutical Co., Ltd.

⚠️ Moderate Risk

FEI: 3008345655 • Shanghai, Shanghai • CHINA

FEI

FEI Number

3008345655

📍

Location

Shanghai, Shanghai

🇨🇳

Country

CHINA
🏢

Address

Zhangjiang Hi-Tech Park, 1479 Zhangheng Road, Shanghai, Shanghai, China

Moderate Risk

FDA Import Risk Assessment

36.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
10/19/2006
Latest Refusal
10/19/2006
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
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

31001×

ANDRO

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to declare and/or contain androstenedione, a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.

Refusal History

DateProductViolationsDivision
10/19/2006
66VAR99MISCELLANEOUS PATENT MEDICINES, ETC.
3100ANDRO
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Shanghai Desano Bio-Pharmaceutical Co., Ltd.'s FDA import refusal history?

Shanghai Desano Bio-Pharmaceutical Co., Ltd. (FEI: 3008345655) has 1 FDA import refusal record(s) in our database, spanning from 10/19/2006 to 10/19/2006.

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. Shanghai Desano Bio-Pharmaceutical Co., Ltd.'s FEI number is 3008345655.

What types of violations has Shanghai Desano Bio-Pharmaceutical Co., Ltd. received?

Shanghai Desano Bio-Pharmaceutical 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 Shanghai Desano Bio-Pharmaceutical Co., Ltd. come from?

All FDA import refusal data for Shanghai Desano Bio-Pharmaceutical 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.