FDA Inspection
Isomedix Operations, Inc.Isomedix Operations, Inc. – FDA Inspection, Jan 8, 2014
Record Details
This FDA Inspection record concerns Isomedix Operations, Inc., with an inspection on January 8, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Isomedix Operations, Inc.
- Inspection Date
- January 8, 2014
- Product Type
- Devices
View Company Profile
ID · f7245ac0-f63c-4c4b-957f-94c14c57cebd
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 862829
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
Other FDA inspections of Isomedix Operations, Inc.
10| Date | Classification | Office | Project area |
|---|---|---|---|
| September 17, 2025 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 19, 2024 | Not classified | Chicago District Office | |
| February 7, 2020 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 30, 2017 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| November 15, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Isomedix Operations, Inc.
- FDA Inspection 1286590 - 2025-09-17
- FDA Inspection 1250741 - 2024-09-19
- FDA Inspection 1121544 - 2020-02-07
- FDA Inspection 1037072 - 2017-11-30
- FDA Inspection 993210 - 2016-11-15
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.