FDA Inspection
Senzime ABSenzime AB – FDA Inspection, Jan 18, 2024
Record Details
This FDA Inspection record concerns Senzime AB, with an inspection on January 18, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · c6884f3d-68a3-487f-a828-8e8bf2eb5e88
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1227196
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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