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Hebei Handform Plastic Products Co., Ltd.

⚠️ Moderate Risk

FEI: 3008388240 • Xingtai • CHINA

FEI

FEI Number

3008388240

📍

Location

Xingtai

🇨🇳

Country

CHINA
🏢

Address

Julu County Industrial Park, , Xingtai, , China

Moderate Risk

FDA Import Risk Assessment

37.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
2/21/2014
Latest Refusal
11/7/2013
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

4773×

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
2/21/2014
80LYZGLOVE, PATIENT EXAMINATION, VINYL
477HOLES
Atlanta District Office (ATL-DO)
11/7/2013
80LYZGLOVE, PATIENT EXAMINATION, VINYL
477HOLES
New York District Office (NYK-DO)
11/7/2013
80LYZGLOVE, PATIENT EXAMINATION, VINYL
477HOLES
New York District Office (NYK-DO)

Frequently Asked Questions

What is Hebei Handform Plastic Products Co., Ltd.'s FDA import refusal history?

Hebei Handform Plastic Products Co., Ltd. (FEI: 3008388240) has 3 FDA import refusal record(s) in our database, spanning from 11/7/2013 to 2/21/2014.

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. Hebei Handform Plastic Products Co., Ltd.'s FEI number is 3008388240.

What types of violations has Hebei Handform Plastic Products Co., Ltd. received?

Hebei Handform Plastic 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 Hebei Handform Plastic Products Co., Ltd. come from?

All FDA import refusal data for Hebei Handform Plastic 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.