FDA Inspection
Magellan Diagnostics, Inc.Magellan Diagnostics, Inc. – FDA Inspection, Oct 21, 2019
Record Details
This FDA Inspection record concerns Magellan Diagnostics, Inc., with an inspection on October 21, 2019, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Magellan Diagnostics, Inc.
- Inspection Date
- October 21, 2019
- Product Type
- Devices
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ID · 532221bd-aa9e-456f-a0a8-c7068abb890a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1107302
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
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Other FDA inspections of Magellan Diagnostics, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| August 26, 2025 | OAI | New England District Office | Compliance: Medical Devices |
| June 22, 2021 | 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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