FDA Inspection
Synergy Health Sterilisation M SDN BHDSynergy Health Sterilisation M SDN BHD – FDA Inspection, Nov 23, 2023
Record Details
This FDA Inspection record concerns Synergy Health Sterilisation M SDN BHD, with an inspection on November 23, 2023, issued by the Office of Inspections and Investigations.
- Inspection Date
- November 23, 2023
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ID · a08b7b9a-93ae-4580-8ac2-000cb7cd3457
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1224946
- FDA center
- Medical Devices & Rad Health
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.70(i)Software validation for automated processes
- 21 CFR 820.75(a)Lack of or inadequate process validation
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Other FDA inspections of Synergy Health Sterilisation M SDN BHD
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 23, 2023 | Not classified | Office of Inspections and Investigations |
Other documents for Synergy Health Sterilisation M SDN BHD
- FDA Inspection 1225443 - 2023-11-23
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