SHIJIAZHUANG ELEGANCE PLASTIC PRODUCTS CO.,LTD
⚠️ Moderate Risk
FEI: 3008718511 • Shijiazhuang, Hebei • CHINA
FEI Number
3008718511
Location
Shijiazhuang, Hebei
Country
CHINAAddress
Building, Zhongyuan Room 201 Unit 2, # 88 Huaian West Rd, 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.
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 |
|---|---|---|---|
| 7/8/2014 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 6/21/2010 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Baltimore District Office (BLT-DO) |
| 5/19/2010 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Southwest Import District Office (SWI-DO) |
| 3/10/2010 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | New England District Office (NWE-DO) |
Frequently Asked Questions
What is SHIJIAZHUANG ELEGANCE PLASTIC PRODUCTS CO.,LTD's FDA import refusal history?
SHIJIAZHUANG ELEGANCE PLASTIC PRODUCTS CO.,LTD (FEI: 3008718511) has 4 FDA import refusal record(s) in our database, spanning from 3/10/2010 to 7/8/2014.
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. SHIJIAZHUANG ELEGANCE PLASTIC PRODUCTS CO.,LTD's FEI number is 3008718511.
What types of violations has SHIJIAZHUANG ELEGANCE PLASTIC PRODUCTS CO.,LTD received?
SHIJIAZHUANG ELEGANCE 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 ELEGANCE PLASTIC PRODUCTS CO.,LTD come from?
All FDA import refusal data for SHIJIAZHUANG ELEGANCE 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.