FDA Inspection
Vitaire Corp.Vitaire Corp. – FDA Inspection, May 9, 2013
Record Details
This FDA Inspection record concerns Vitaire Corp., with an inspection on May 9, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Vitaire Corp.
- Inspection Date
- May 9, 2013
- Product Type
- Devices
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ID · a2dba2ea-bda1-405a-8b2b-91a76c16442e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 831609
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.20(a)Quality policy and objectives
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Other FDA inspections of Vitaire Corp.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 24, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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