# FDA 483 - Heartware, Inc. - May 04, 2016

Source: https://www.keypedia.com/records/483/heartware-inc/08c011b3-65b5-47b5-bf2b-8f8b8e8f1f4b

> FDA 483 for Heartware, Inc. on May 04, 2016. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Heartware, Inc.
- Inspection Date: 2016-05-04
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: HeartWare, Inc. in Miami Lakes, FL, a medical device manufacturer, was cited for significant deficiencies across its quality system. The inspection revealed inadequate procedures for MDR reporting, corrective and preventive actions, complaint handling, process validation, design transfer, servicing verification, and supplier management. These issues indicate a systemic failure to ensure product quality, safety, and regulatory compliance for their vascular assisted devices.

## Related Documents

- [483 - 2014-01-24](https://www.keypedia.com/records/483/heartware-inc/c477e339-7f14-4aaf-bd4c-1515bd0c6e95)
- [483 - 2021-09-30](https://www.keypedia.com/records/483/heartware-inc/8eccb497-c1b0-47d2-b89f-a87a3abad0a2)

## Related Officers

- [Sean T. Creighton](https://www.keypedia.com/people/sean-t-creighton/80ffecab-0a2d-4727-a11f-407b697f4503)
- [Dianiris C. Ayala](https://www.keypedia.com/people/dianiris-c-ayala/ba6c5538-201b-4c9a-8f23-e160db6868e6)

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

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