FDA Inspection
Isomedix Operations IncIsomedix Operations Inc – FDA Inspection, Nov 30, 2017
Record Details
This FDA Inspection record concerns Isomedix Operations Inc, with an inspection on November 30, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f5c69d20-a140-46e8-bdd3-b47d70471a42
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1032396
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
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 | |
| July 25, 2022 | 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 1177943 - 2022-07-25
- FDA Inspection 899490 - 2014-10-10
- FDA Inspection 794210 - 2012-08-09
- FDA Inspection 644445 - 2010-01-27
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