Shandong Zibo Shanchuan Medical Instrument Co. Ltd.
⚠️ Moderate Risk
FEI: 3003499913 • Zibo, Shandong • CHINA
FEI Number
3003499913
Location
Zibo, Shandong
Country
CHINAAddress
No. 88 Shanchuan Road, Chengnanzhen Zichuan District, 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
DEVICEGMPS
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/8/2016 | 80FMFSYRINGE, PISTON | 2780DEVICEGMPS | New Orleans District Office (NOL-DO) |
| 11/13/2012 | 80FMFSYRINGE, PISTON | 2780DEVICEGMPS | Baltimore District Office (BLT-DO) |
| 11/13/2012 | 80FMFSYRINGE, PISTON | 2780DEVICEGMPS | Baltimore District Office (BLT-DO) |
| 11/13/2012 | 80FMFSYRINGE, PISTON | 2780DEVICEGMPS | Baltimore District Office (BLT-DO) |
| 11/13/2012 | 80FMFSYRINGE, PISTON | 2780DEVICEGMPS | Baltimore District Office (BLT-DO) |
Frequently Asked Questions
What is Shandong Zibo Shanchuan Medical Instrument Co. Ltd.'s FDA import refusal history?
Shandong Zibo Shanchuan Medical Instrument Co. Ltd. (FEI: 3003499913) has 5 FDA import refusal record(s) in our database, spanning from 11/13/2012 to 3/8/2016.
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. Shandong Zibo Shanchuan Medical Instrument Co. Ltd.'s FEI number is 3003499913.
What types of violations has Shandong Zibo Shanchuan Medical Instrument Co. Ltd. received?
Shandong Zibo Shanchuan Medical Instrument 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 Zibo Shanchuan Medical Instrument Co. Ltd. come from?
All FDA import refusal data for Shandong Zibo Shanchuan Medical Instrument 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.