Overview
- 16 FDA inspections are on record.
- 9 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-05-22.
At a glance
Inspections
16
Form 483s
9
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 6 May 2024 – 22 May 2024 | Medical Devices & Rad Health | 483 | View 483 → |
| 28 Feb 2022 – 10 Mar 2022 | Medical Devices & Rad Health | Clean | |
| 2 Mar 2020 – 6 Apr 2020 | Medical Devices & Rad Health | 483 | View 483 → |
| 17 Jul 2018 – 6 Sep 2018 | Medical Devices & Rad Health | 483 | View 483 → |
| 25 Aug 2016 – 30 Sep 2016 | Medical Devices & Rad Health | 483 | On file |
| 6 Aug 2014 – 29 Sep 2014 | Medical Devices & Rad Health | 483 | On file |
| 18 Dec 2012 | Not recorded | 483 | View 483 → |
| 8 Oct 2010 | Not recorded | 483 | View 483 → |
| 10 Nov 2009 | Not recorded | Clean | |
| 1 Sep 2009 | Not recorded | 483 | On file |
| 1 Feb 2008 | Not recorded | 483 | On file |
| 22 Jun 2005 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
22 May 2024
21 CFR 820.198(a)
Lack of or inadequate complaint procedures
Cited by Janet Pulver, Linda Galindo
22 May 2024
21 CFR 820.30(g)
Design Validation - Risk analysis not performed/inadequate
Cited by Janet Pulver, Linda Galindo
Investigators
FDA investigators tied to this site in the record.
Scott K Zika5 insp.
Janet Pulver2 insp.
Charles L Larson2 insp.
Linda Galindo1 insp.
Matthew M Vernon1 insp.
Linda Linh N Adams1 insp.
Maria Isabe Tejero Del Rio1 insp.
Kirtida Patel1 insp.
Sean T Creighton1 insp.
Shaquenta Y Perkins1 insp.
Cntrctmntr Anderson1 insp.
Vickie L Anderson1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 803.17 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 803.50(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 803.56 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 806.10(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.200(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind CareFusion 303, Inc.'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