FDA Inspection
Bodystat Ltd.Bodystat Ltd. – FDA Inspection, Dec 18, 2018
Record Details
This FDA Inspection record concerns Bodystat Ltd., with an inspection on December 18, 2018, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · 67373540-17cd-4dc5-b8a7-bc663912022d
Inspection Facts
- Inspection number
- 1074830
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(c)Design input - documentation
- 21 CFR 820.30(d)Design output - Lack of or inadequate procedures
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation - software validation not performed
- 21 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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