FDA Inspection
Heartware, Inc.Heartware, Inc. – FDA Inspection, Jul 21, 2017
Record Details
This FDA Inspection record concerns Heartware, Inc., with an inspection on July 21, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 4c59db07-42e3-414a-a844-8dc894cc2fa7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1020202
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
Other FDA inspections of Heartware, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 31, 2015 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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