FDA Inspection
Isomedix Operations, Inc.Isomedix Operations, Inc. – FDA Inspection, Jan 27, 2026
Record Details
This FDA Inspection record concerns Isomedix Operations, Inc., with an inspection on January 27, 2026, issued by the Chicago District Office, covering biologics.
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ID · 0444fff6-b3f0-4e9a-85eb-f05508af2737
Inspection Facts
- Inspection number
- 1300188
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
3- 21 CFR 1271.180(a)Procedures to meet core CTGP
- 21 CFR 1271.200(e)Documentation of maintenance and cleaning
- 21 CFR 1271.260(e)Storage temperatures recorded, maintained
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Other FDA inspections of Isomedix Operations, Inc.
8| Date | Classification | Office | Project area |
|---|---|---|---|
| September 23, 2024 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 18, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| 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 1250815 - 2024-09-23
- FDA Inspection 1219550 - 2023-09-18
- FDA Inspection 998533 - 2017-01-09
- FDA Inspection 943630 - 2015-12-03
- FDA Inspection 800833 - 2012-09-28
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