FDA Inspection 940483 - Heartware, Inc. - July 31, 2015

Record Details

This FDA Inspection record concerns Heartware, Inc., with an inspection on July 31, 2015, issued by the Center for Devices and Radiological Health, covering devices.

Company: Heartware, Inc.
Inspection Date: July 31, 2015
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · 0a447584-a900-420b-a434-0c9c7acb3fca

Violation Codes5

21 CFR 820.100(a)21 CFR 820.20(c)21 CFR 820.30(g)21 CFR 820.30(i)21 CFR 820.50

Full citation text and observation details available on the Dashboard.

FDA Inspection

Heartware, Inc.July 31, 2015

FDA Inspection 940483 - Heartware, Inc. - July 31, 2015

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Record Details

This FDA Inspection record concerns Heartware, Inc., with an inspection on July 31, 2015, issued by the Center for Devices and Radiological Health, covering devices.

Company: Heartware, Inc.
Inspection Date: July 31, 2015
Product Type: Devices
Office: Center for Devices and Radiological Health

Open in Dashboard

ID · 0a447584-a900-420b-a434-0c9c7acb3fca

Violation Codes5

21 CFR 820.100(a)21 CFR 820.20(c)21 CFR 820.30(g)21 CFR 820.30(i)21 CFR 820.50

Full citation text and observation details available on the Dashboard.