# FDA 483 - Heartware, Inc. - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/heartware-inc/7fbee088-0faa-421d-8562-7d52974cf769

> FDA 483 for Heartware, Inc. on Unknown Date. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Heartware, Inc.
- Product Type: other
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: Heartware, Inc., a sponsor of investigational studies, was cited for two observations during an FDA inspection. The firm failed to promptly secure compliance from a clinical investigator regarding trial data and adverse event reporting, even as the site became overwhelmed with open queries. Additionally, a monitor failed to submit monitoring visit reports within the required timeframe for another protocol.

## Related Officers

- [Byungja E. Marciante](https://www.globalkeysolutions.net/people/byungja-e-marciante/5d1f2927-9017-4ab6-8ad2-521e340ef14f)

Company: https://www.globalkeysolutions.net/companies/heartware-inc/3737dbe4-524b-4da4-b3bc-8c564221c1d4

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7