Company
United StatesThoratec LLC, Pleasanton, CA – FDA Inspections
Inspection records and compliance data for Thoratec LLC in Pleasanton, California. 10 FDA inspections on record, 1 Form 483, last inspected May 30, 2025.
Company Profile
This profile covers Thoratec LLC based in Pleasanton, California, United States.
FDA Inspection History
- FDA inspections
- 10
- OAI
- 0
- VAI
- 4
- NAI
- 6
- Form 483s
- 1
- Warning letters
- 0
First inspected November 12, 2008. Last inspected May 30, 2025.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Documentation1 inspection
FDA inspections (10)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 30, 2025 | VAI | Medical Devices & Rad Health · Compliance: Medical Devices | 1269802 |
| October 9, 2020 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1132047 |
| June 12, 2017 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1020165 |
| November 23, 2015 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 948389 |
| February 28, 2014 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 866589 |
| July 15, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 839933 |
| May 18, 2012 | NAI | Medical Devices & Rad Health · Compliance: Devices | 786667 |
| September 7, 2011 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 741711 |
| November 17, 2009 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 632284 |
| November 12, 2008 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 548949 |
FDA documents
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Thoratec LLC
FEI Number
2916596
Address
6035 Stoneridge Dr, Pleasanton, California 94588, United States
Country
United States
ID: 0565188b-cc7b-4a8a-bbda-7b41b2571c7e