FDA Inspection
Thoratec LLCFDA Inspection 1269802 - Thoratec LLC - May 30, 2025
Record Details
This FDA Inspection record concerns Thoratec LLC, with an inspection on May 30, 2025, covering devices.
- Company
- Thoratec LLC
- Inspection Date
- May 30, 2025
- Product Type
- Devices
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ID · c417f302-fa42-45ec-a47b-87b25917647a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1269802
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
2- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
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Other FDA inspections of Thoratec LLC
9| Date | Classification | Office | Project area |
|---|---|---|---|
| October 9, 2020 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 12, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 23, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 28, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 15, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Thoratec LLC
- FDA Inspection 1132047 - 2020-10-09
- FDA Inspection 1020165 - 2017-06-12
- FDA Inspection 948389 - 2015-11-23
- FDA Inspection 866589 - 2014-02-28
- FDA Inspection 839933 - 2013-07-15
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