FDA Inspection
SELVAS Healthcare, Inc.SELVAS Healthcare, Inc. – FDA Inspection, May 23, 2019
Record Details
This FDA Inspection record concerns SELVAS Healthcare, Inc., with an inspection on May 23, 2019, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · 9bb9e046-b06d-4a3c-9c4b-d65bc3610563
Inspection Facts
- Inspection number
- 1092640
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 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 - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.70(i)Software validation for automated processes
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
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