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

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Record Details

This FDA Inspection record concerns Magellan Diagnostics, Inc., with an inspection on August 26, 2025, issued by the Center for Devices and Radiological Health, covering devices.

Company: Magellan Diagnostics, Inc.
Inspection Date: August 26, 2025
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · 976c7cba-e7b5-45d1-9bd6-bf32c671d9f4

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)

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