SHIJIAZHUANG HONGZAN PLASTIC TECHNOLOGY CO.,LTD
⚠️ Moderate Risk
FEI: 3003070952 • Zanhuang • CHINA
FEI Number
3003070952
Location
Zanhuang
Country
CHINAAddress
DONGGAO INDUSTRIAL ZONE, , Zanhuang, , 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.
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/6/2018 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of West Coast Imports (DWCI) |
| 6/4/2010 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/4/2010 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 5/4/2009 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | New York District Office (NYK-DO) |
| 4/22/2009 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | New York District Office (NYK-DO) |
| 4/17/2003 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Southwest Import District Office (SWI-DO) |
| 4/17/2003 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Southwest Import District Office (SWI-DO) |
| 2/10/2003 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is SHIJIAZHUANG HONGZAN PLASTIC TECHNOLOGY CO.,LTD's FDA import refusal history?
SHIJIAZHUANG HONGZAN PLASTIC TECHNOLOGY CO.,LTD (FEI: 3003070952) has 8 FDA import refusal record(s) in our database, spanning from 2/10/2003 to 4/6/2018.
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 HONGZAN PLASTIC TECHNOLOGY CO.,LTD's FEI number is 3003070952.
What types of violations has SHIJIAZHUANG HONGZAN PLASTIC TECHNOLOGY CO.,LTD received?
SHIJIAZHUANG HONGZAN PLASTIC TECHNOLOGY 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 HONGZAN PLASTIC TECHNOLOGY CO.,LTD come from?
All FDA import refusal data for SHIJIAZHUANG HONGZAN PLASTIC TECHNOLOGY 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.