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Shanghai Chuangshi Medical Technology (Group) Co., Ltd.

✅ Low Risk

FEI: 3005023997 • Shanghai, Shanghai • CHINA

FEI

FEI Number

3005023997

📍

Location

Shanghai, Shanghai

🇨🇳

Country

CHINA
🏢

Address

388 Zhangliantang Road, Qingpu, 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
6/12/2021
Latest Refusal
6/12/2021
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
6/12/2021
62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL)
118NOT LISTED
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is Shanghai Chuangshi Medical Technology (Group) Co., Ltd.'s FDA import refusal history?

Shanghai Chuangshi Medical Technology (Group) Co., Ltd. (FEI: 3005023997) has 1 FDA import refusal record(s) in our database, spanning from 6/12/2021 to 6/12/2021.

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 Chuangshi Medical Technology (Group) Co., Ltd.'s FEI number is 3005023997.

What types of violations has Shanghai Chuangshi Medical Technology (Group) Co., Ltd. received?

Shanghai Chuangshi Medical Technology (Group) 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 Chuangshi Medical Technology (Group) Co., Ltd. come from?

All FDA import refusal data for Shanghai Chuangshi Medical Technology (Group) 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.