SHIJIAZHUANG GLORY PLASTIC CO LTD

⚠️ High Risk

FEI: 3009137438 • Shijiazhuang, Hebei • CHINA

FEI

FEI Number

3009137438

📍

Location

Shijiazhuang, Hebei

🇨🇳

Country

CHINA

🏢

Address

Room 1502 Unit 3, # 76 Huaian East Road, Shijiazhuang, Hebei, China

High Risk

FDA Import Risk Assessment

55.6

LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

Total Refusals

Unique Violations

11/30/2016

Latest Refusal

10/19/2012

Earliest Refusal

Score Breakdown

Violation Severity

70.0×40%

Refusal Volume

59.7×30%

Recency

0.0×20%

Frequency

97.1×10%

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

47740×

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

Date	Product	Violations	Division
11/30/2016	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Atlanta District Office (ATL-DO)
11/30/2016	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Atlanta District Office (ATL-DO)
11/30/2016	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Atlanta District Office (ATL-DO)
11/30/2016	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Atlanta District Office (ATL-DO)
11/30/2016	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Atlanta District Office (ATL-DO)
11/30/2016	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Atlanta District Office (ATL-DO)
11/29/2016	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Division of West Coast Imports (DWCI)
11/29/2016	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Division of West Coast Imports (DWCI)
11/29/2016	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Division of West Coast Imports (DWCI)
11/29/2016	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Division of West Coast Imports (DWCI)
11/29/2016	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Division of West Coast Imports (DWCI)
11/29/2016	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Division of West Coast Imports (DWCI)
11/29/2016	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Division of West Coast Imports (DWCI)
11/29/2016	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Division of West Coast Imports (DWCI)
11/29/2016	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Division of West Coast Imports (DWCI)
11/29/2016	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Division of West Coast Imports (DWCI)
11/29/2016	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Division of West Coast Imports (DWCI)
11/25/2016	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	New England District Office (NWE-DO)
11/25/2016	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	New England District Office (NWE-DO)
11/25/2016	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	New England District Office (NWE-DO)
11/25/2016	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	New England District Office (NWE-DO)
11/25/2016	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	New England District Office (NWE-DO)
11/25/2016	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	New England District Office (NWE-DO)
11/25/2016	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	New England District Office (NWE-DO)
11/25/2016	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	New England District Office (NWE-DO)
11/25/2016	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	New England District Office (NWE-DO)
11/25/2016	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	New England District Office (NWE-DO)
11/25/2016	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	New England District Office (NWE-DO)
11/25/2016	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	New England District Office (NWE-DO)
11/22/2016	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	New England District Office (NWE-DO)
11/22/2016	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	New England District Office (NWE-DO)
11/22/2016	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	New England District Office (NWE-DO)
11/22/2016	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	New England District Office (NWE-DO)
11/22/2016	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	New England District Office (NWE-DO)
11/22/2016	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	New England District Office (NWE-DO)
11/3/2016	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Division of West Coast Imports (DWCI)
11/3/2016	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Division of West Coast Imports (DWCI)
11/3/2016	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Division of West Coast Imports (DWCI)
8/4/2014	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	Southwest Import District Office (SWI-DO)
10/19/2012	80LYZGLOVE, PATIENT EXAMINATION, VINYL	477HOLES	New England District Office (NWE-DO)

Frequently Asked Questions

What is SHIJIAZHUANG GLORY PLASTIC CO LTD's FDA import refusal history?

SHIJIAZHUANG GLORY PLASTIC CO LTD (FEI: 3009137438) has 40 FDA import refusal record(s) in our database, spanning from 10/19/2012 to 11/30/2016.

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 GLORY PLASTIC CO LTD's FEI number is 3009137438.

What types of violations has SHIJIAZHUANG GLORY PLASTIC CO LTD received?

SHIJIAZHUANG GLORY PLASTIC 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 SHIJIAZHUANG GLORY PLASTIC CO LTD come from?

All FDA import refusal data for SHIJIAZHUANG GLORY PLASTIC 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.