FDA Inspection
Magellan Diagnostics, Inc.FDA Inspection 1280392 - Magellan Diagnostics, Inc. - August 26, 2025
Discuss this record with AI
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.
Record Details
This FDA Inspection record concerns Magellan Diagnostics, Inc., with an inspection on August 26, 2025, covering devices.
Open in Dashboard
ID · d8c3df10-e214-49c7-bb22-03a850d407f1
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.