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Shanghai Motex Healthcare Co., Ltd.

⚠️ Moderate Risk

FEI: 3003045222 • Shanghai • CHINA

FEI

FEI Number

3003045222

📍

Location

Shanghai

🇨🇳

Country

CHINA
🏢

Address

No. 369, Middle Jia Song Road,, Huaxin, Oing Pu, Shanghai, , China

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
6/27/2012
Latest Refusal
6/27/2012
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

161×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

Refusal History

DateProductViolationsDivision
6/27/2012
80LZAGLOVE, PATIENT EXAMINATION, POLY
16DIRECTIONS
Chicago District Office (CHI-DO)

Frequently Asked Questions

What is Shanghai Motex Healthcare Co., Ltd.'s FDA import refusal history?

Shanghai Motex Healthcare Co., Ltd. (FEI: 3003045222) has 1 FDA import refusal record(s) in our database, spanning from 6/27/2012 to 6/27/2012.

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 Motex Healthcare Co., Ltd.'s FEI number is 3003045222.

What types of violations has Shanghai Motex Healthcare Co., Ltd. received?

Shanghai Motex Healthcare 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 Motex Healthcare Co., Ltd. come from?

All FDA import refusal data for Shanghai Motex Healthcare 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.