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Shanghai Freemen LifeScience Co., Ltd.

✅ Low Risk

FEI: 3003169366 • Shanghai, Shanghai • CHINA

FEI

FEI Number

3003169366

📍

Location

Shanghai, Shanghai

🇨🇳

Country

CHINA
🏢

Address

Building 19, 2500 Xiupulu, Shanghai, Shanghai, China

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
1
Unique Violations
4/10/2002
Latest Refusal
4/10/2002
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
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

1181×

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).

Refusal History

DateProductViolationsDivision
4/10/2002
64RCY99HORMONE N.E.C.
118NOT LISTED
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Shanghai Freemen LifeScience Co., Ltd.'s FDA import refusal history?

Shanghai Freemen LifeScience Co., Ltd. (FEI: 3003169366) has 1 FDA import refusal record(s) in our database, spanning from 4/10/2002 to 4/10/2002.

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 Freemen LifeScience Co., Ltd.'s FEI number is 3003169366.

What types of violations has Shanghai Freemen LifeScience Co., Ltd. received?

Shanghai Freemen LifeScience 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 Freemen LifeScience Co., Ltd. come from?

All FDA import refusal data for Shanghai Freemen LifeScience 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.