FDA Inspection
KindaraKindara – FDA Inspection, Feb 8, 2017
Record Details
This FDA Inspection record concerns Kindara, with an inspection on February 8, 2017, issued by the Denver District Office, covering medical devices & rad health.
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ID · cc6e2b90-13b6-4d20-8bd0-508fe9e7ddb8
Inspection Facts
- Inspection number
- 1001292
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.30(g)Design validation - documentation
- 21 CFR 820.30(g)Design validation - software validation not performed
- 21 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
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