FDA Inspection
SISU Global HealthSISU Global Health – FDA Inspection, Jun 27, 2019
Record Details
This FDA Inspection record concerns SISU Global Health, with an inspection on June 27, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · c5dfd2f5-d09d-46f1-b2b1-483de60954c1
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1094356
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 820.70(i)Software validation for automated processes
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