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SHANGHAI SNWI MEDICAL CO., LTD

⚠️ Moderate Risk

FEI: 3016764422 • D 4288 Du, Shanghai • CHINA

FEI

FEI Number

3016764422

📍

Location

D 4288 Du, Shanghai

🇨🇳

Country

CHINA
🏢

Address

Rm D522, Zone, D 4288 Du, Shanghai, China

Moderate Risk

FDA Import Risk Assessment

33.8
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
6/1/2023
Latest Refusal
6/1/2023
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
47.1×20%
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
6/1/2023
80KGOSURGEON'S GLOVES
118NOT LISTED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is SHANGHAI SNWI MEDICAL CO., LTD's FDA import refusal history?

SHANGHAI SNWI MEDICAL CO., LTD (FEI: 3016764422) has 1 FDA import refusal record(s) in our database, spanning from 6/1/2023 to 6/1/2023.

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 SNWI MEDICAL CO., LTD's FEI number is 3016764422.

What types of violations has SHANGHAI SNWI MEDICAL CO., LTD received?

SHANGHAI SNWI MEDICAL 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 SNWI MEDICAL CO., LTD come from?

All FDA import refusal data for SHANGHAI SNWI MEDICAL 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.