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Shanghai Sun Biological Products Co. Ltd

⚠️ Moderate Risk

FEI: 3005715641 • Shanghai, Shanghai • CHINA

FEI

FEI Number

3005715641

📍

Location

Shanghai, Shanghai

🇨🇳

Country

CHINA
🏢

Address

351 Guosoujing Roadzhangjiang High-Teck, , Shanghai, Shanghai, China

Moderate Risk

FDA Import Risk Assessment

42.5
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
8/7/2009
Latest Refusal
11/15/2007
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
11.6×10%
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

752×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
8/7/2009
54FBY99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
11/15/2007
54YAR99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
New York District Office (NYK-DO)

Frequently Asked Questions

What is Shanghai Sun Biological Products Co. Ltd's FDA import refusal history?

Shanghai Sun Biological Products Co. Ltd (FEI: 3005715641) has 2 FDA import refusal record(s) in our database, spanning from 11/15/2007 to 8/7/2009.

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. Shanghai Sun Biological Products Co. Ltd's FEI number is 3005715641.

What types of violations has Shanghai Sun Biological Products Co. Ltd received?

Shanghai Sun Biological Products 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 Sun Biological Products Co. Ltd come from?

All FDA import refusal data for Shanghai Sun Biological Products 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.