FDA Inspection
Isomedix Operations Inc.Isomedix Operations Inc. – FDA Inspection, Nov 7, 2019
Record Details
This FDA Inspection record concerns Isomedix Operations Inc., with an inspection on November 7, 2019, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Isomedix Operations Inc.
- Inspection Date
- November 7, 2019
- Product Type
- Devices
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ID · 300b6043-aecb-4b4d-a3aa-376b159f3ada
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1109042
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.160(b)Distribution records
- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
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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 |
| April 12, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Isomedix Operations Inc.
- FDA Inspection 1264291 - 2025-02-21
- FDA Inspection 1168479 - 2022-04-12
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