FDA Inspection
Sterigenics US, LLCSterigenics US, LLC – FDA Inspection, Jul 6, 2017
Record Details
This FDA Inspection record concerns Sterigenics US, LLC, with an inspection on July 6, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · bcd52e58-26d8-47b7-ae96-dd3ab6f98fd7
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1017915
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.75(a)Lack of or inadequate process validation
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Other FDA inspections of Sterigenics US, LLC
6| Date | Classification | Office | Project area |
|---|---|---|---|
| February 28, 2025 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 7, 2017 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| February 11, 2015 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| November 26, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 7, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Sterigenics US, LLC
- FDA Inspection 1265113 - 2025-02-28
- FDA Inspection 1013355 - 2017-04-07
- FDA Inspection 913117 - 2015-02-11
- FDA Inspection 809586 - 2012-11-26
- FDA Inspection 745140 - 2011-10-07
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