FDA Inspection 1196985 - Outset Medical, Inc. - February 10, 2023

FDA Inspection 1196985 for Outset Medical, Inc. on February 10, 2023. Classification: Voluntary Action Indicated (VAI).

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Record Summary

FDA Inspection 1196985 for Outset Medical, Inc. on February 10, 2023. Classification: Voluntary Action Indicated (VAI).

Violation Codes

21 CFR 803.50(a)(1)

21 CFR 820.100(b)

21 CFR 820.30(g)

21 CFR 820.90(b)(1)

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Record Information

Company

Outset Medical, Inc.

Inspection Date

February 10, 2023

Product Type

Devices

Office

Center for Devices and Radiological Health

ID: f48f04f6-7177-4134-8044-e2358201a0ad

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