Shijiazhuang Junfei Plastic Products Co., ltd.

⚠️ Moderate Risk

FEI: 3003124366 • Shijiazhuang, Hebei • CHINA

FEI

FEI Number

3003124366

📍

Location

Shijiazhuang, Hebei

🇨🇳

Country

CHINA

🏢

Address

Donggao Industrial Zone, , Shijiazhuang, Hebei, China

Moderate Risk

FDA Import Risk Assessment

40.9

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

2/2/2018

Latest Refusal

8/30/2006

Earliest Refusal

Score Breakdown

Violation Severity

66.5×40%

Refusal Volume

43.6×30%

Recency

0.0×20%

Frequency

12.2×10%

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

Violation Summary

47714×

HOLES

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

4843×

DV NAME

The article appears to be a device and its labeling fails to bear the proprietary or established name.

Refusal History

Date	Product	Violations	Division
2/2/2018	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES 484DV NAME	Division of Southeast Imports (DSEI)
2/2/2018	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES 484DV NAME	Division of Southeast Imports (DSEI)
2/2/2018	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES 484DV NAME	Division of Southeast Imports (DSEI)
4/21/2014	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Atlanta District Office (ATL-DO)
4/21/2014	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Atlanta District Office (ATL-DO)
4/21/2014	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Atlanta District Office (ATL-DO)
4/21/2014	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Atlanta District Office (ATL-DO)
11/3/2011	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Chicago District Office (CHI-DO)
11/3/2011	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Chicago District Office (CHI-DO)
11/3/2011	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Chicago District Office (CHI-DO)
11/3/2011	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Chicago District Office (CHI-DO)
11/6/2009	80LZAGLOVE, PATIENT EXAMINATION, POLY	477HOLES	Southwest Import District Office (SWI-DO)
10/19/2009	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	New York District Office (NYK-DO)
8/30/2006	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Chicago District Office (CHI-DO)

Frequently Asked Questions

What is Shijiazhuang Junfei Plastic Products Co., ltd.'s FDA import refusal history?

Shijiazhuang Junfei Plastic Products Co., ltd. (FEI: 3003124366) has 14 FDA import refusal record(s) in our database, spanning from 8/30/2006 to 2/2/2018.

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. Shijiazhuang Junfei Plastic Products Co., ltd.'s FEI number is 3003124366.

What types of violations has Shijiazhuang Junfei Plastic Products Co., ltd. received?

Shijiazhuang Junfei Plastic Products Co., ltd. has been cited for 2 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 Shijiazhuang Junfei Plastic Products Co., ltd. come from?

All FDA import refusal data for Shijiazhuang Junfei 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.