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

FDA Inspection 1280392 for Magellan Diagnostics, Inc. on August 26, 2025. Classification: OAI.

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Record Summary

FDA Inspection 1280392 for Magellan Diagnostics, Inc. on August 26, 2025. Classification: OAI.

Violation Codes

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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Record Information

Company

Magellan Diagnostics, Inc.

Inspection Date

August 26, 2025

Product Type

Medical Devices & Rad Health

Office

New England District Office

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

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