Thoratec LLCApril 24, 2025

FDA 483 - Thoratec LLC - April 24, 2025

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Record Details

Thoratec LLC in Pleasanton, CA, received two observations during an FDA inspection. The firm was cited for inadequately established procedures for design changes, specifically regarding software validation testing for device updates. Additionally, corrective and preventive action activities were not adequately documented, with an investigation failing to assess all possible issues for a Class 3 medical device.

Company: Thoratec LLC
Inspection Date: April 24, 2025
Product Type: Device
Office: Division of Human and Animal Food Operations - West V
People: Karen M. Cruz Arenas
Kenya Destin

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ID · c53fae11-a8ac-4955-aefe-1f54fc2d1bd8