FDA Inspection
Vitaire Corp.Vitaire Corp. – FDA Inspection, Jan 24, 2018
Record Details
This FDA Inspection record concerns Vitaire Corp., with an inspection on January 24, 2018, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Melissa A. Zuppe
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ID · b504c0f7-64c1-48b3-8459-c09f4e4dc825
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1038504
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
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Other FDA inspections of Vitaire Corp.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 9, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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