FDA Inspection 1058645 - Heartware, Inc. - July 12, 2018

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Record Details

This FDA Inspection record concerns Heartware, Inc., with an inspection on July 12, 2018, issued by the Center for Devices and Radiological Health, covering devices.

Company: Heartware, Inc.
Inspection Date: July 12, 2018
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · 5104d940-d430-4459-991f-cda75adfd4e0

Violation Codes7

21 CFR 803.1721 CFR 820.100(a)21 CFR 820.198(a)21 CFR 820.25(b)21 CFR 820.30(a)21 CFR 820.30(g)21 CFR 820.50

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