Company
ChinaSunmed AP, Ltd., Zhuhai, China – FDA Inspections
Inspection records and compliance data for Sunmed AP, Ltd. in Zhuhai. 4 FDA inspections on record, 1 Form 483, last inspected March 05, 2026.
Company Profile
This profile covers Sunmed AP, Ltd. based in Zhuhai, China.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 1
- NAI
- 2
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected March 4, 2010. Last inspected March 5, 2026.
Most cited issue areas
- Design and development transfer procedures not documented1 inspection
- Failure to register1 inspection
- Process for production and service provision not validated1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 5, 2026 | Not classified | Medical Devices & Rad Health · Compliance: Medical Devices | 1311202 |
| March 31, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 977038 |
| May 30, 2013 | NAI | Medical Devices & Rad Health · Compliance: Devices | 843271 |
| March 4, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 657579 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Sunmed AP, Ltd.
FEI Number
3005998497
Address
Qianwu Industry Park, Doume District, Zhuhai, China
Country
China
ID: 1cae60c8-9372-4736-b280-51fdfab1b28e