FDA Inspection
Sterigenics US, LLCSterigenics US, LLC – FDA Inspection, Oct 21, 2019
Record Details
This FDA Inspection record concerns Sterigenics US, LLC, with an inspection on October 21, 2019, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Sterigenics US, LLC
- Inspection Date
- October 21, 2019
- Product Type
- Devices
View Company Profile
ID · 3ce144ea-3d6c-46c1-b9a1-72df6726b625
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1106995
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
Other FDA inspections of Sterigenics US, LLC
11| Date | Classification | Office | Project area |
|---|---|---|---|
| December 3, 2025 | Not classified | Atlanta District Office | |
| April 8, 2025 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| 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 |
| 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 1266423 - 2025-04-08
- FDA Inspection 1190626 - 2022-10-25
- FDA Inspection 1137201 - 2021-03-04
- FDA Inspection 1106089 - 2019-08-26
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