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Shanghai Pt Plastics Enterprise Co., Ltd.

⚠️ Moderate Risk

FEI: 3000237484 • Shanghai, Shanghai • CHINA

FEI

FEI Number

3000237484

📍

Location

Shanghai, Shanghai

🇨🇳

Country

CHINA
🏢

Address

Township 268 Cangqiaolong, Songjiang County, Shanghai, 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
12/6/2011
Latest Refusal
12/6/2011
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

4771×

HOLES

The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.

Refusal History

DateProductViolationsDivision
12/6/2011
80LYZGLOVE, PATIENT EXAMINATION, VINYL
477HOLES
New York District Office (NYK-DO)

Frequently Asked Questions

What is Shanghai Pt Plastics Enterprise Co., Ltd.'s FDA import refusal history?

Shanghai Pt Plastics Enterprise Co., Ltd. (FEI: 3000237484) has 1 FDA import refusal record(s) in our database, spanning from 12/6/2011 to 12/6/2011.

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. Shanghai Pt Plastics Enterprise Co., Ltd.'s FEI number is 3000237484.

What types of violations has Shanghai Pt Plastics Enterprise Co., Ltd. received?

Shanghai Pt Plastics Enterprise 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 Pt Plastics Enterprise Co., Ltd. come from?

All FDA import refusal data for Shanghai Pt Plastics Enterprise 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.