FDA Inspection
Isomedix Operations Inc.Isomedix Operations Inc. – FDA Inspection, Sep 15, 2023
Record Details
This FDA Inspection record concerns Isomedix Operations Inc., with an inspection on September 15, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 36c3e318-1c90-4d44-a06b-a87336ca5e85
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1217934
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
Other FDA inspections of Isomedix Operations Inc.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| July 17, 2026 | Not classified | Minneapolis District Office | Project Evaluation: Devices |
| January 26, 2024 | Not classified | Minneapolis District Office | |
| July 17, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 13, 2016 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| January 14, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Isomedix Operations Inc.
- FDA Inspection 1327498 - 2026-07-17
- FDA Inspection 1231745 - 2024-01-26
- FDA Inspection 1060499 - 2018-07-17
- FDA Inspection 966619 - 2016-04-13
- FDA Inspection 863123 - 2014-01-14
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