FDA Inspection
Isomedix Operations IncIsomedix Operations Inc – FDA Inspection, Aug 9, 2012
Record Details
This FDA Inspection record concerns Isomedix Operations Inc, with an inspection on August 9, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Isomedix Operations Inc
- Inspection Date
- August 9, 2012
- Product Type
- Drugs
View Company Profile
ID · f2c41690-dea3-471e-9711-afdabf5e04ec
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 794210
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 211.194(a)Complete test data included in records
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 |
| 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 |
| 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 1032396 - 2017-11-30
- FDA Inspection 899490 - 2014-10-10
- FDA Inspection 644445 - 2010-01-27
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