SHIJIAZHUANG PROSPEROUS PLASTIC CO., LTD
⚠️ Moderate Risk
FEI: 3007143709 • Shijiazhuang City • CHINA
FEI Number
3007143709
Location
Shijiazhuang City
Country
CHINAAddress
Taitou Huaian Road, , Shijiazhuang City, , 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.
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/29/2014 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Southwest Import District Office (SWI-DO) |
| 7/1/2014 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Southwest Import District Office (SWI-DO) |
| 12/17/2013 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Atlanta District Office (ATL-DO) |
| 11/18/2013 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Los Angeles District Office (LOS-DO) |
| 11/1/2013 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Baltimore District Office (BLT-DO) |
| 10/22/2013 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Baltimore District Office (BLT-DO) |
| 8/7/2013 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Southwest Import District Office (SWI-DO) |
| 1/6/2012 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Florida District Office (FLA-DO) |
| 1/6/2012 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Florida District Office (FLA-DO) |
| 12/6/2011 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Los Angeles District Office (LOS-DO) |
| 12/6/2011 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Los Angeles District Office (LOS-DO) |
| 12/6/2011 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Los Angeles District Office (LOS-DO) |
| 11/21/2011 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Chicago District Office (CHI-DO) |
| 11/21/2011 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Chicago District Office (CHI-DO) |
| 11/21/2011 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Chicago District Office (CHI-DO) |
| 6/11/2009 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Los Angeles District Office (LOS-DO) |
| 6/4/2009 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | New York District Office (NYK-DO) |
| 6/4/2009 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | New York District Office (NYK-DO) |
| 4/29/2009 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Atlanta District Office (ATL-DO) |
| 4/29/2009 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 126FAILS STD | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is SHIJIAZHUANG PROSPEROUS PLASTIC CO., LTD's FDA import refusal history?
SHIJIAZHUANG PROSPEROUS PLASTIC CO., LTD (FEI: 3007143709) has 20 FDA import refusal record(s) in our database, spanning from 4/29/2009 to 7/29/2014.
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 PROSPEROUS PLASTIC CO., LTD's FEI number is 3007143709.
What types of violations has SHIJIAZHUANG PROSPEROUS PLASTIC CO., LTD received?
SHIJIAZHUANG PROSPEROUS 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 PROSPEROUS PLASTIC CO., LTD come from?
All FDA import refusal data for SHIJIAZHUANG PROSPEROUS 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.