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Meixin Medical Suzhou Co., Ltd.

⚠️ Moderate Risk

FEI: 3003255800 • Suzhou City, Jiangsu • CHINA

FEI

FEI Number

3003255800

📍

Location

Suzhou City, Jiangsu

🇨🇳

Country

CHINA
🏢

Address

Tongli Town, Wujiang District, Jiangsu Province, Suzhou City, Jiangsu, China

Moderate Risk

FDA Import Risk Assessment

27.9
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
8/10/2011
Latest Refusal
1/9/2009
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
22.3×30%
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

1183×

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
8/10/2011
79FSMTRAY, SURGICAL, INSTRUMENT
118NOT LISTED
Southwest Import District Office (SWI-DO)
1/9/2009
80FNYBASIN, EMESIS
118NOT LISTED
New Orleans District Office (NOL-DO)
1/9/2009
80KYXDISPENSER, LIQUID MEDICATION
118NOT LISTED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Meixin Medical Suzhou Co., Ltd.'s FDA import refusal history?

Meixin Medical Suzhou Co., Ltd. (FEI: 3003255800) has 3 FDA import refusal record(s) in our database, spanning from 1/9/2009 to 8/10/2011.

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. Meixin Medical Suzhou Co., Ltd.'s FEI number is 3003255800.

What types of violations has Meixin Medical Suzhou Co., Ltd. received?

Meixin Medical Suzhou 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 Meixin Medical Suzhou Co., Ltd. come from?

All FDA import refusal data for Meixin Medical Suzhou 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.