# FDA 483 - Thoratec LLC - May 30, 2025

Source: https://www.globalkeysolutions.net/records/483/thoratec-llc/e427d094-1a4e-4e2c-8493-8c300861c9b7

> FDA 483 for Thoratec LLC on May 30, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Thoratec LLC
- Inspection Date: 2025-05-30
- Product Type: device
- Office Name: San Francisco District Office
- Summary: An FDA inspection of Thoratec LLC in Pleasanton, CA, a medical device manufacturer, identified two significant observations. The firm was cited for inadequately established procedures for design changes, specifically regarding software validation testing. Additionally, corrective and preventive action activities were found to be insufficiently documented, with a specific CAPA failing to investigate all potential issues.

## Related Documents

- [483 - 2025-04-24](https://www.globalkeysolutions.net/records/483/thoratec-llc/c53fae11-a8ac-4955-aefe-1f54fc2d1bd8)

## Related Officers

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

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

Office: https://www.globalkeysolutions.net/offices/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df