FDA Inspection
IncludeHealthIncludeHealth – FDA Inspection, Nov 1, 2023
Record Details
This FDA Inspection record concerns IncludeHealth, with an inspection on November 1, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 2322daa3-166a-4a0d-b145-8aa041f90965
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1221808
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation - software validation not performed
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