# FDA 483 - Thoratec LLC - April 24, 2025

Source: https://www.globalkeysolutions.net/records/483/thoratec-llc/c53fae11-a8ac-4955-aefe-1f54fc2d1bd8

> FDA 483 for Thoratec LLC on April 24, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Thoratec LLC
- Inspection Date: 2025-04-24
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: 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.

## Related Documents

- [483 - 2025-05-30](https://www.globalkeysolutions.net/records/483/thoratec-llc/e427d094-1a4e-4e2c-8493-8c300861c9b7)

## Related Officers

- [Karen M. Cruz Arenas](https://www.globalkeysolutions.net/people/karen-m-cruz-arenas/6c698301-84ca-4ba7-a79c-309721db2f1b)
- [Kenya Destin](https://www.globalkeysolutions.net/people/kenya-destin/1a367d64-8171-4dfd-bb1f-78d8b96a99f5)

Company: https://www.globalkeysolutions.net/companies/thoratec-llc/0565188b-cc7b-4a8a-bbda-7b41b2571c7e

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b