Overview
- 16 FDA inspections are on record.
- 9 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-05-30.
At a glance
Inspections
16
Form 483s
9
EIRs
4
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 7 Apr 2025 – 30 May 2025 | Medical Devices & Rad Health | 483 | View 483 → |
| 7 Apr 2025 – 24 Apr 2025 | Medical Devices & Rad Health | 483 | View 483 → |
| 6 Oct 2020 – 9 Oct 2020 | Medical Devices & Rad Health | Clean | |
| 5 Jun 2017 – 12 Jun 2017 | Medical Devices & Rad Health | Clean | |
| 10 Nov 2015 – 23 Nov 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 18 Feb 2014 – 28 Feb 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 2 Jul 2013 – 15 Jul 2013 | Medical Devices & Rad Health | 483 | View 483 → |
| 18 May 2012 | Not recorded | 483 | View 483 → |
| 7 Sep 2011 | Not recorded | 483 | View 483 → |
| 17 Nov 2009 | Not recorded | 483 | On file |
| 12 Nov 2008 | Not recorded | 483 | On file |
| 24 Oct 2007 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
30 May 2025
21 CFR 820.30(i)
Design changes - Lack of or Inadequate Procedures
Cited by Kenya Destin, Karen M Cruz Arenas
24 Apr 2025
21 CFR 820.30(i)
Design changes - Lack of or Inadequate Procedures
Cited by Kenya Destin, Karen M Cruz Arenas
23 Nov 2015
21 CFR 820.250(a)
Statistical techniques - Lack of or inadequate procedures
Cited by Adam S Freeman
Investigators
FDA investigators tied to this site in the record.
Kenya Destin2 insp.
Karen M Cruz Arenas2 insp.
Lydia S Chan2 insp.
Christine M Parmentier2 insp.
Maida Henesian1 insp.
Harjap K Atwal1 insp.
James A Lane1 insp.
Adam S Freeman1 insp.
Jude C Dike1 insp.
Cristina O Dar1 insp.
Linda Linh T Nguyen1 insp.
Eric W Anderson1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 7x |
| 21 CFR 820.250(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.50(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 803.50(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(g)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Thoratec LLC's 9 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat