FDA Inspection
Steris Corporation Hopkins FacilitySteris Corporation Hopkins Facility – FDA Inspection, Apr 12, 2011
Record Details
This FDA Inspection record concerns Steris Corporation Hopkins Facility, with an inspection on April 12, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- April 12, 2011
- Product Type
- Devices
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ID · aa28b979-7c78-4a0f-a055-7fcd1f0acf8e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 713862
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.80(b)Incoming acceptance records, documentation
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.60Identification procedures, Lack of or inadequate procedures
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Other FDA inspections of Steris Corporation Hopkins Facility
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 19, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 12, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 6, 2009 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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