Shandong Hengchang Medical Technology Co., Ltd
⚠️ Moderate Risk
FEI: 3008111599 • Zibo, Shandong • CHINA
FEI Number
3008111599
Location
Zibo, Shandong
Country
CHINAAddress
Science/Tech. Park In Zhangdian, No 12 Sanying Road; Fangzhenzhen Zhangdian, Zibo, Shandong, 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 |
|---|---|---|---|
| 8/23/2022 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of West Coast Imports (DWCI) |
| 3/7/2013 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | New England District Office (NWE-DO) |
| 3/7/2013 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | New England District Office (NWE-DO) |
| 3/7/2013 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | New England District Office (NWE-DO) |
| 3/7/2013 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | New England District Office (NWE-DO) |
| 8/29/2008 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | New England District Office (NWE-DO) |
| 9/18/2006 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is Shandong Hengchang Medical Technology Co., Ltd's FDA import refusal history?
Shandong Hengchang Medical Technology Co., Ltd (FEI: 3008111599) has 7 FDA import refusal record(s) in our database, spanning from 9/18/2006 to 8/23/2022.
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. Shandong Hengchang Medical Technology Co., Ltd's FEI number is 3008111599.
What types of violations has Shandong Hengchang Medical Technology Co., Ltd received?
Shandong Hengchang Medical Technology 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 Shandong Hengchang Medical Technology Co., Ltd come from?
All FDA import refusal data for Shandong Hengchang Medical 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.