FDA Inspection
Sterigenics US, LLCSterigenics US, LLC – FDA Inspection, May 4, 2023
Record Details
This FDA Inspection record concerns Sterigenics US, LLC, with an inspection on May 4, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · d06bc18f-63c7-4faa-ac5d-0fbe41f8c9eb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1204411
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.72(b)Remedial action
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Other FDA inspections of Sterigenics US, LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| March 19, 2026 | NAI | Compliance: Devices | |
| February 11, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 23, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 14, 2009 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Sterigenics US, LLC
- FDA Inspection 1311656 - 2026-03-19
- FDA Inspection 812881 - 2013-02-11
- FDA Inspection 673208 - 2010-07-23
- FDA Inspection 597608 - 2009-07-14
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