FDA Inspection
Isomedix Operations, Inc.Isomedix Operations, Inc. – FDA Inspection, Sep 18, 2023
Record Details
This FDA Inspection record concerns Isomedix Operations, Inc., with an inspection on September 18, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · b6e8aec3-f94d-402f-88ae-0d4a6b838da3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1219550
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
Other FDA inspections of Isomedix Operations, Inc.
8| Date | Classification | Office | Project area |
|---|---|---|---|
| January 27, 2026 | Not classified | Chicago District Office | Human Cellular, Tissue, and Gene Therapies |
| September 23, 2024 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 9, 2017 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| December 3, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 28, 2012 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
Other documents for Isomedix Operations, Inc.
- FDA Inspection 1300188 - 2026-01-27
- FDA Inspection 1250815 - 2024-09-23
- FDA Inspection 998533 - 2017-01-09
- FDA Inspection 943630 - 2015-12-03
- FDA Inspection 800833 - 2012-09-28
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