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POLYMED XIAMEN PLASTIC INDUSTRIA

⚠️ Moderate Risk

FEI: 3012982611 • Xiamen • CHINA

FEI

FEI Number

3012982611

📍

Location

Xiamen

🇨🇳

Country

CHINA
🏢

Address

Unit B, 1-5F No G; Warehouse & Process B, Xiamen, , China

Moderate Risk

FDA Import Risk Assessment

25.1
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
3/31/2023
Latest Refusal
3/31/2023
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
Refusal Volume
11.2×30%
Recency
43.9×20%
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

3411×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

Refusal History

DateProductViolationsDivision
3/31/2023
73KGBMASK, OXYGEN, NON-REBREATHING
341REGISTERED
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is POLYMED XIAMEN PLASTIC INDUSTRIA's FDA import refusal history?

POLYMED XIAMEN PLASTIC INDUSTRIA (FEI: 3012982611) has 1 FDA import refusal record(s) in our database, spanning from 3/31/2023 to 3/31/2023.

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. POLYMED XIAMEN PLASTIC INDUSTRIA's FEI number is 3012982611.

What types of violations has POLYMED XIAMEN PLASTIC INDUSTRIA received?

POLYMED XIAMEN PLASTIC INDUSTRIA 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 POLYMED XIAMEN PLASTIC INDUSTRIA come from?

All FDA import refusal data for POLYMED XIAMEN PLASTIC INDUSTRIA 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.