FDA Inspection
Isomedix Operations Inc.Isomedix Operations Inc. – FDA Inspection, Apr 12, 2022
Record Details
This FDA Inspection record concerns Isomedix Operations Inc., with an inspection on April 12, 2022, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Isomedix Operations Inc.
- Inspection Date
- April 12, 2022
- Product Type
- Devices
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ID · b337dcb8-d0c4-4fc2-8e59-e65602bc457b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1168479
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Isomedix Operations Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 21, 2025 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 7, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Isomedix Operations Inc.
- FDA Inspection 1264291 - 2025-02-21
- FDA Inspection 1109042 - 2019-11-07
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