Keystone Heart LtdOctober 29, 2020

FDA 483 - Keystone Heart Ltd - October 29, 2020

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Record Details

An FDA inspection of Keystone Heart Ltd in Tampa, FL, identified a significant issue regarding an investigational study. The firm failed to promptly inform the FDA about critical new information concerning their REFLECT study, specifically a pause and resumption of enrollment due to a Data Monitoring Committee decision. This indicates a failure in timely communication of significant study changes to the regulatory body.

Company: Keystone Heart Ltd
Inspection Date: October 29, 2020
Product Type: Other
Office: Office of Medical Device and Radiological Health Division II
People: Latrice G. Jones (issuing_officer)
Jonathan R. Campos

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ID · 246f5a56-f726-4767-917a-213e490fe222