Company
ChinaShandong Zibo Shanchuan Medical Instrument Co. Ltd., Zibo, China – FDA Inspections
Inspection records and compliance data for Shandong Zibo Shanchuan Medical Instrument Co. Ltd. in Zibo. 1 FDA inspection on record (1 OAI), 1 warning letter, last inspected October 27, 2011.
Company Profile
This profile covers Shandong Zibo Shanchuan Medical Instrument Co. Ltd. based in Zibo, China.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 1
- VAI
- 0
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 1
Inspected October 27, 2011.
Most cited issue areas
- Calibration, Inspection, etc. Procedures Lack of or Inadequ1 inspection
- Design changes - Lack of or Inadequate Procedures1 inspection
- DHR - not or inadequately maintained1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 27, 2011 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 752315 |
FDA documents
Warning Letters (1)
Other regulators (1)
- China NMPA · 1 inspection · last May 23, 2016
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Company Information
Name
Shandong Zibo Shanchuan Medical Instrument Co. Ltd.
FEI Number
3003499913
Address
No. 88 Shanchuan Road; Chengnan Town Zichuan District, Zibo, China
Country
China
ID: 4721e717-10fc-44f9-8a00-4c95a835d084