FDA Inspection
Sterigenics US, LLCSterigenics US, LLC – FDA Inspection, Apr 8, 2025
Record Details
This FDA Inspection record concerns Sterigenics US, LLC, with an inspection on April 8, 2025, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 9aaee2f8-da62-479d-b404-19e5896aa8c8
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1266423
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
Other FDA inspections of Sterigenics US, LLC
11| Date | Classification | Office | Project area |
|---|---|---|---|
| December 3, 2025 | Not classified | Atlanta District Office | |
| October 25, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 4, 2021 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 21, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 26, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Sterigenics US, LLC
- FDA Inspection 1294490 - 2025-12-03
- FDA Inspection 1190626 - 2022-10-25
- FDA Inspection 1137201 - 2021-03-04
- FDA Inspection 1106995 - 2019-10-21
- FDA Inspection 1106089 - 2019-08-26
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