Hebei Leader Plastic Co., Ltd.
⚠️ Moderate Risk
FEI: 3010047788 • Shijiazhuang, Hebei • CHINA
FEI Number
3010047788
Location
Shijiazhuang, Hebei
Country
CHINAAddress
77 Zhongshan 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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/10/2016 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Seattle District Office (SEA-DO) |
| 8/10/2016 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Seattle District Office (SEA-DO) |
| 1/9/2014 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Cincinnati District Office (CIN-DO) |
| 12/2/2013 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Hebei Leader Plastic Co., Ltd.'s FDA import refusal history?
Hebei Leader Plastic Co., Ltd. (FEI: 3010047788) has 4 FDA import refusal record(s) in our database, spanning from 12/2/2013 to 8/10/2016.
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. Hebei Leader Plastic Co., Ltd.'s FEI number is 3010047788.
What types of violations has Hebei Leader Plastic Co., Ltd. received?
Hebei Leader 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 Hebei Leader Plastic Co., Ltd. come from?
All FDA import refusal data for Hebei Leader 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.