FDA Inspection
Steris Corporation Hopkins FacilitySteris Corporation Hopkins Facility – FDA Inspection, Jun 12, 2012
Record Details
This FDA Inspection record concerns Steris Corporation Hopkins Facility, with an inspection on June 12, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- June 12, 2012
- Product Type
- Devices
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ID · 9114ce74-9230-4408-b16c-1fad6096d818
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 786100
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.75(a)Lack of or inadequate process validation
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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 |
| April 12, 2011 | 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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