SHIJIAZHUANG JIUYUAN PLASTIC CO., LTD
⚠️ Moderate Risk
FEI: 3009756996 • Shijiazhuang, Hebei • CHINA
FEI Number
3009756996
Location
Shijiazhuang, Hebei
Country
CHINAAddress
Xibaipo Industry Park, Pingshan County, Shijiazhuang, Hebei, China
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
HOLES
The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/5/2018 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of Southwest Imports (DSWI) |
| 9/5/2018 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of Southwest Imports (DSWI) |
| 9/5/2018 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of Southwest Imports (DSWI) |
| 8/13/2018 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of Southeast Imports (DSEI) |
| 8/13/2018 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of Southeast Imports (DSEI) |
| 8/13/2018 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of Southeast Imports (DSEI) |
| 8/13/2018 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of Southeast Imports (DSEI) |
| 5/4/2018 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of West Coast Imports (DWCI) |
| 5/4/2018 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of West Coast Imports (DWCI) |
| 5/4/2018 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of West Coast Imports (DWCI) |
| 5/4/2018 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of West Coast Imports (DWCI) |
| 5/4/2018 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of West Coast Imports (DWCI) |
| 5/4/2018 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of West Coast Imports (DWCI) |
| 5/4/2018 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of West Coast Imports (DWCI) |
| 5/4/2018 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of West Coast Imports (DWCI) |
| 5/4/2018 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of West Coast Imports (DWCI) |
| 7/29/2014 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Southwest Import District Office (SWI-DO) |
| 6/9/2014 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | Southwest Import District Office (SWI-DO) | |
| 5/21/2014 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Southwest Import District Office (SWI-DO) |
| 9/9/2010 | 80LZCGLOVE, PATIENT EXAMINATION, SPECIALTY | 477HOLES | Baltimore District Office (BLT-DO) |
| 9/9/2010 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Baltimore District Office (BLT-DO) |
| 9/9/2010 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Baltimore District Office (BLT-DO) |
| 9/9/2010 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Baltimore District Office (BLT-DO) |
| 9/9/2010 | 80LZCGLOVE, PATIENT EXAMINATION, SPECIALTY | 477HOLES | Baltimore District Office (BLT-DO) |
| 9/9/2010 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Baltimore District Office (BLT-DO) |
Frequently Asked Questions
What is SHIJIAZHUANG JIUYUAN PLASTIC CO., LTD's FDA import refusal history?
SHIJIAZHUANG JIUYUAN PLASTIC CO., LTD (FEI: 3009756996) has 25 FDA import refusal record(s) in our database, spanning from 9/9/2010 to 9/5/2018.
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 JIUYUAN PLASTIC CO., LTD's FEI number is 3009756996.
What types of violations has SHIJIAZHUANG JIUYUAN PLASTIC CO., LTD received?
SHIJIAZHUANG JIUYUAN PLASTIC 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 JIUYUAN PLASTIC CO., LTD come from?
All FDA import refusal data for SHIJIAZHUANG JIUYUAN 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.