FDA Inspection
IonisosIonisos – FDA Inspection, Sep 12, 2024
Record Details
This FDA Inspection record concerns Ionisos, with an inspection on September 12, 2024, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · edf2ecf1-740a-4be6-846b-cd0bdbcb3d98
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1249495
- FDA center
- Medical Devices & Rad Health
- Project area
- Product Evaluation: Medical Devices
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.70(i)Software validation for automated processes
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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