FDA Inspection
Isomedix Operations IncIsomedix Operations Inc – FDA Inspection, Jul 25, 2022
Record Details
This FDA Inspection record concerns Isomedix Operations Inc, with an inspection on July 25, 2022, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Isomedix Operations Inc
- Inspection Date
- July 25, 2022
- Product Type
- Devices
View Company Profile
ID · 2a421d5c-69f8-4423-a4be-ea690694a069
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1177943
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.75(a)Lack of or inadequate process validation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Isomedix Operations Inc
5| Date | Classification | Office | Project area |
|---|---|---|---|
| June 17, 2025 | Not classified | Cincinnati District Office | |
| November 30, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 10, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 9, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 27, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Isomedix Operations Inc
- FDA Inspection 1276319 - 2025-06-17
- FDA Inspection 1032396 - 2017-11-30
- FDA Inspection 899490 - 2014-10-10
- FDA Inspection 794210 - 2012-08-09
- FDA Inspection 644445 - 2010-01-27
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.