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ZHONGHONG PULIN MEDICAL PRODUCTS CO.,LTD.

⚠️ Moderate Risk

FEI: 3010201834 • Tangshan City, Hebei • CHINA

FEI

FEI Number

3010201834

📍

Location

Tangshan City, Hebei

🇨🇳

Country

CHINA
🏢

Address

West Industrial Park, BDA, Luannan County, , Tangshan City, Hebei, China

Moderate Risk

FDA Import Risk Assessment

47.4
LowModerateHighCritical

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

Statistics

11
Total Refusals
1
Unique Violations
3/28/2018
Latest Refusal
9/28/2016
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
40.0×30%
Recency
0.0×20%
Frequency
73.5×10%
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

47711×

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
3/28/2018
80LYZGLOVE, PATIENT EXAMINATION, VINYL
477HOLES
Division of Northern Border Imports (DNBI)
3/28/2018
80LYZGLOVE, PATIENT EXAMINATION, VINYL
477HOLES
Division of Northern Border Imports (DNBI)
11/7/2017
80LYZGLOVE, PATIENT EXAMINATION, VINYL
477HOLES
Division of West Coast Imports (DWCI)
11/7/2017
80LYZGLOVE, PATIENT EXAMINATION, VINYL
477HOLES
Division of West Coast Imports (DWCI)
10/16/2017
80LYZGLOVE, PATIENT EXAMINATION, VINYL
477HOLES
Division of West Coast Imports (DWCI)
9/28/2016
80LYZGLOVE, PATIENT EXAMINATION, VINYL
477HOLES
Division of West Coast Imports (DWCI)
9/28/2016
80LYZGLOVE, PATIENT EXAMINATION, VINYL
477HOLES
Division of West Coast Imports (DWCI)
9/28/2016
80LYZGLOVE, PATIENT EXAMINATION, VINYL
477HOLES
Division of West Coast Imports (DWCI)
9/28/2016
80LYZGLOVE, PATIENT EXAMINATION, VINYL
477HOLES
Division of West Coast Imports (DWCI)
9/28/2016
80LYZGLOVE, PATIENT EXAMINATION, VINYL
477HOLES
Division of West Coast Imports (DWCI)
9/28/2016
80LYZGLOVE, PATIENT EXAMINATION, VINYL
477HOLES
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is ZHONGHONG PULIN MEDICAL PRODUCTS CO.,LTD.'s FDA import refusal history?

ZHONGHONG PULIN MEDICAL PRODUCTS CO.,LTD. (FEI: 3010201834) has 11 FDA import refusal record(s) in our database, spanning from 9/28/2016 to 3/28/2018.

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. ZHONGHONG PULIN MEDICAL PRODUCTS CO.,LTD.'s FEI number is 3010201834.

What types of violations has ZHONGHONG PULIN MEDICAL PRODUCTS CO.,LTD. received?

ZHONGHONG PULIN MEDICAL PRODUCTS 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 ZHONGHONG PULIN MEDICAL PRODUCTS CO.,LTD. come from?

All FDA import refusal data for ZHONGHONG PULIN MEDICAL PRODUCTS 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.