FDA Inspection
SterisSteris – FDA Inspection, May 10, 2018
Record Details
This FDA Inspection record concerns Steris, with an inspection on May 10, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · c95a8696-4894-44bd-b1af-6f1f8e4c9cb3
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1051379
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.50(b)Supplier notification of changes
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Steris
4| Date | Classification | Office | Project area |
|---|---|---|---|
| May 24, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 2, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 2, 2010 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 6, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Steris
- FDA Inspection 1170217 - 2022-05-24
- FDA Inspection 842695 - 2013-08-02
- FDA Inspection 695837 - 2010-11-02
- FDA Inspection 582973 - 2009-05-06
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