FDA Inspection
Sterigenics US, LLCSterigenics US, LLC – FDA Inspection, Apr 7, 2017
Record Details
This FDA Inspection record concerns Sterigenics US, LLC, with an inspection on April 7, 2017, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · ed96339c-90ba-4680-943e-cfbb854d17a8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1013355
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
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 |
| July 6, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| 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 1017915 - 2017-07-06
- FDA Inspection 913117 - 2015-02-11
- FDA Inspection 809586 - 2012-11-26
- FDA Inspection 745140 - 2011-10-07
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.