483
Heartware, Inc.FDA 483 - Heartware, Inc.
Record Details
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.
- Company
- Heartware, Inc.
- Product Type
- Other
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ID · 7fbee088-0faa-421d-8562-7d52974cf769