FDA Inspection 1280392 - Magellan Diagnostics, Inc. - August 26, 2025

View on Dashboard

Discuss this record with AI

ChatGPT

Claude

Perplexity

Grok

Copilot

Document or profile

One record shows the event. A profile shows the pattern.

Buy this document for the source file and details behind this single event.

Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.

Explore Magellan Diagnostics, Inc.

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

Open in Dashboard

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

Violation Codes9

21 CFR 803.17(a)(1)21 CFR 803.50(a)(2)21 CFR 806.10(a)(2)21 CFR 820.100(a)21 CFR 820.250(b)21 CFR 820.30(f)21 CFR 820.30(g)21 CFR 820.75(a)21 CFR 820.80(b)

Full citation text and observation details available on the Dashboard.

FDA Inspection

Magellan Diagnostics, Inc.August 26, 2025