FDA Inspection
Isomedix Operations Inc.Isomedix Operations Inc. – FDA Inspection, Jul 17, 2026
Record Details
This FDA Inspection record concerns Isomedix Operations Inc., with an inspection on July 17, 2026, issued by the Minneapolis District Office, covering medical devices & rad health.
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ID · ace1864f-1b4b-4d58-8bf8-b22bcc1102d2
Inspection Facts
- Inspection number
- 1327498
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
2- ISO 13485:2016 Clause 7.5.1Production controls not adequate
- ISO 13485:2016 Clause 8.4Procedures for analysis of data not documented
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Isomedix Operations Inc.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| January 26, 2024 | Not classified | Minneapolis District Office | |
| September 15, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| 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 1231745 - 2024-01-26
- FDA Inspection 1217934 - 2023-09-15
- FDA Inspection 1060499 - 2018-07-17
- FDA Inspection 966619 - 2016-04-13
- FDA Inspection 863123 - 2014-01-14
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