# FDA 483 - Heartware, Inc. - September 30, 2021

Source: https://www.globalkeysolutions.net/records/483/heartware-inc/8eccb497-c1b0-47d2-b89f-a87a3abad0a2

> FDA 483 for Heartware, Inc. on September 30, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Heartware, Inc.
- Inspection Date: 2021-09-30
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II

## Related Documents

- [483 - 2021-09-30](https://www.globalkeysolutions.net/records/483/heartware-inc/ed7dede5-c23f-471a-9de8-9c2f8e65c275)
- [483 - 2014-01-24](https://www.globalkeysolutions.net/records/483/heartware-inc/c477e339-7f14-4aaf-bd4c-1515bd0c6e95)
- [483 - 2016-05-04](https://www.globalkeysolutions.net/records/483/heartware-inc/08c011b3-65b5-47b5-bf2b-8f8b8e8f1f4b)

## Related Officers

- [Stanley R Rugene](https://www.globalkeysolutions.net/people/stanley-r-rugene/4c8374d1-b3b3-42ca-b897-8ccbcf22f5ab)
- [Dianiris C. Ayala](https://www.globalkeysolutions.net/people/dianiris-c-ayala/ba6c5538-201b-4c9a-8f23-e160db6868e6)
- [investigator](https://www.globalkeysolutions.net/people/karen-m-rodriguez/fcef1f49-583d-45ab-80e2-4c34793fd722)

Company: https://www.globalkeysolutions.net/companies/heartware-inc/fc9e730f-ca60-46ac-9b88-23a426f2dbfe

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6