FDA Inspection 713862 — Steris Corporation Hopkins Facility
The FDA completed an inspection of Steris Corporation Hopkins Facility on April 12, 2011 in Mentor, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 12, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Mentor, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3269 | 21 CFR 820.80(b) | Incoming acceptance records, documentation |
| 502 | 21 CFR 820.60 | Identification procedures, Lack of or inadequate procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |