FDA Inspection
Sterigenics US LLCSterigenics US LLC – FDA Inspection, Apr 26, 2017
Record Details
This FDA Inspection record concerns Sterigenics US LLC, with an inspection on April 26, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 8adcc75f-2274-4b3a-8b24-e0ee97da27aa
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1009920
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.100(a)Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Sterigenics US LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| May 28, 2025 | NAI | Postmarket Assurance: Devices | |
| June 22, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 6, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 8, 2011 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| June 19, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Sterigenics US LLC
- FDA Inspection 1271833 - 2025-05-28
- FDA Inspection 1173787 - 2022-06-22
- FDA Inspection 870254 - 2014-03-06
- FDA Inspection 752268 - 2011-11-08
- FDA Inspection 592377 - 2009-06-19
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