FDA Inspection 617014 — Steris Corporation
The FDA completed an inspection of Steris Corporation on November 6, 2009 in Mentor, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 6, 2009
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Mentor, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3688 | 21 CFR 820.100(a)(1) | Analysis of data/reports from data sources |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |