FDA Inspection
Magellan Diagnostics, Inc.Magellan Diagnostics, Inc. – FDA Inspection, Jun 22, 2021
Record Details
This FDA Inspection record concerns Magellan Diagnostics, Inc., with an inspection on June 22, 2021, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Magellan Diagnostics, Inc.
- Inspection Date
- June 22, 2021
- Product Type
- Devices
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ID · 7cc14c22-8447-401c-a00a-ad646a238767
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1144696
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.75(a)Lack of or inadequate process validation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Magellan Diagnostics, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| August 26, 2025 | OAI | New England District Office | Compliance: Medical Devices |
| October 21, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 29, 2017 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 25, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 23, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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