Magellan Diagnostics, Inc. – FDA Inspection, Aug 26, 2025

Record Details

This FDA Inspection record concerns Magellan Diagnostics, Inc., with an inspection on August 26, 2025, issued by the New England District Office, covering medical devices & rad health.

Company: Magellan Diagnostics, Inc.
Inspection Date: August 26, 2025
Product Type: Medical Devices & Rad Health
Office: New England District Office
Person: Sunita Pandey (Issuing Officer)

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ID · fd15f720-9b1c-4475-bbe3-cf2f14911055

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number: 1280392
FDA center: Medical Devices & Rad Health
Project area: Compliance: Medical Devices
Outcome: Form 483 issued, view the record

FDA Citations

21 CFR 820.250(b)Sampling plans
21 CFR 803.50(a)(2)Individual Report of Malfunction
21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.75(a)Lack of or inadequate process validation
21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
21 CFR 803.17(a)(1)Lack of System for Event Evaluations
21 CFR 806.10(a)(2)Report of violation of the Act (see 803.52(e)(9))

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Other FDA inspections of Magellan Diagnostics, Inc.

Date	Classification	Office	Project area
June 22, 2021	VAI	Center for Devices and Radiological Health	Compliance: 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