FDA Inspection
Agiliti Health - HaysAgiliti Health - Hays – FDA Inspection, Jun 21, 2013
Record Details
This FDA Inspection record concerns Agiliti Health - Hays, with an inspection on June 21, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Agiliti Health - Hays
- Inspection Date
- June 21, 2013
- Product Type
- Devices
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ID · 3e8c188e-8442-490f-9bad-02f829d45e4a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 840246
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation - documentation
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Other FDA inspections of Agiliti Health - Hays
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 18, 2011 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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