483
Thoratec LLCFDA 483 - Thoratec LLC - May 30, 2025
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Record Details
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.
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ID · e427d094-1a4e-4e2c-8493-8c300861c9b7