FDA Inspection
ZIOSOFT, INC.ZIOSOFT, INC. – FDA Inspection, Dec 18, 2025
Record Details
This FDA Inspection record concerns ZIOSOFT, INC., with an inspection on December 18, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · ef5f8b82-1a89-4df9-9429-0e374cd1180a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1296688
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
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