Company
United StatesSynergy Health Sterilisation M SDN BHD – FDA Inspections
Inspection records and compliance data for Synergy Health Sterilisation M SDN BHD. 2 FDA inspections on record, 1 Form 483, last inspected November 23, 2023.
Company Profile
This profile covers Synergy Health Sterilisation M SDN BHD.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
Inspected November 23, 2023.
Most cited issue areas
- Lack of or inadequate process validation1 inspection
- Software validation for automated processes1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 23, 2023 | Not classified | Medical Devices & Rad Health | 1225443 |
| November 23, 2023 | VAI | Medical Devices & Rad Health | 1224946 |
FDA documents
Form 483s (1)
People (1)
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Company Information
Name
Synergy Health Sterilisation M SDN BHD
FEI Number
3010220595
ID: 54b1c556-b637-4a61-9f87-2e3013a9c464