FDA Inspection 835255 — Agiliti Health - Ellis
The FDA completed an inspection of Agiliti Health - Ellis on May 24, 2013 in Ellis, KS. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 24, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Ellis, KS (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3191 | 21 CFR 820.30(g) | Design validation - production units |
| 3270 | 21 CFR 820.80(c) | Documentation |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 4057 | 21 CFR 820.20(a) | Management ensuring quality policy is understood |