Overview
- 11 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-10-24.
At a glance
Inspections
11
Form 483s
7
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 15 Oct 2025 – 24 Oct 2025 | Human Drugs | WL | View 483 → |
| 18 Sep 2023 – 29 Sep 2023 | Human Drugs | 483 | View 483 → |
| 6 Dec 2016 – 15 Dec 2016 | Human Drugs | 483 | View 483 → |
| 17 Jun 2015 – 25 Jun 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 11 Mar 2014 | Medical Devices & Rad Health | Clean | |
| 28 Jan 2013 – 8 Feb 2013 | Human Drugs | 483 | On file |
| 3 Jun 2011 | Not recorded | 483 | View 483 → |
| 27 Jan 2011 | Not recorded | 483 | View 483 → |
| 16 Dec 2009 | Not recorded | Clean | |
| 13 Jun 2008 | Not recorded | Clean | |
| 2 Aug 2006 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
Following/documenting laboratory controls
Cited by Michael T Cyrus, Inga M Warr, Brittny C Cargo, Rodney L Tinzie
Scientifically sound laboratory controls
Cited by Michael T Cyrus, Inga M Warr, Brittny C Cargo, Rodney L Tinzie
Batch production and Batch Control Record Requirements
Cited by Michael T Cyrus, Inga M Warr, Brittny C Cargo, Rodney L Tinzie
Procedures not in writing, fully followed
Cited by Michael T Cyrus, Inga M Warr, Brittny C Cargo, Rodney L Tinzie
Sanitation--buildings not clean, free of infestation
Cited by Michael T Cyrus, Inga M Warr, Brittny C Cargo, Rodney L Tinzie
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.46(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.84(d)(1) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.94(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind CareFusion 213, LLC's 7 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