Company
United StatesThoratec Corporation, Burlington, MA – FDA Inspections
Inspection records and compliance data for Thoratec Corporation in Burlington, Massachusetts. 5 FDA inspections on record, 1 Form 483, 1 warning letter, last inspected May 17, 2018.
Company Profile
This profile covers Thoratec Corporation based in Burlington, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 2
- NAI
- 3
- Form 483s
- 1
- Warning letters
- 1
First inspected October 13, 2009. Last inspected May 17, 2018.
Most cited issue areas
- Sponsors" general responsibilities2 inspections
- Management review participants1 inspection
- Quality Audit/Reaudit - conducted1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 17, 2018 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 1054905 |
| April 3, 2017 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 1006393 |
| May 30, 2014 | NAI | Medical Devices & Rad Health · Compliance: Devices | 880973 |
| March 16, 2012 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 772501 |
| October 13, 2009 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 629437 |
FDA documents
Warning Letters (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Thoratec Corporation
FEI Number
1218444
Address
23 4th Ave, Burlington, Massachusetts 01803, United States
Country
United States
ID: 9895e06d-2699-4cd6-acfe-c45f50254a01