Overview
- 12 FDA inspections are on record.
- 9 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-02-09.
At a glance
Inspections
12
Form 483s
9
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 29 Jan 2024 – 9 Feb 2024 | Human Drugs | 483 | View 483 → |
| 23 Oct 2023 – 31 Oct 2023 | Biologics | 483 | View 483 → |
| 2 May 2022 – 12 May 2022 | Biologics | 483 | View 483 → |
| 23 Jun 2021 – 1 Jul 2021 | Human Drugs | Clean | |
| 6 Nov 2017 – 17 Nov 2017 | Human Drugs | 483 | View 483 → |
| 17 Feb 2016 – 26 Feb 2016 | Human Drugs | 483 | View 483 → |
| 15 Jan 2014 – 24 Jan 2014 | Human Drugs | 483 | View 483 → |
| 16 Nov 2012 | Not recorded | 483 | View 483 → |
| 31 Aug 2012 | Not recorded | 483 | View 483 → |
| 27 Aug 2010 | Not recorded | Clean | |
| 19 Aug 2009 | Not recorded | 483 | On file |
| 21 Aug 2008 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
9 Feb 2024
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Veronica Fuentes, Libia M Lugo, Susan T Hadman, Demario L Walls
9 Feb 2024
21 CFR 211.110(a)
Control procedures fail to include the following
Cited by Veronica Fuentes, Libia M Lugo, Susan T Hadman, Demario L Walls
9 Feb 2024
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Veronica Fuentes, Libia M Lugo, Susan T Hadman, Demario L Walls
9 Feb 2024
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Veronica Fuentes, Libia M Lugo, Susan T Hadman, Demario L Walls
9 Feb 2024
21 CFR 211.198(a)
Complaint Handling Procedure
Cited by Veronica Fuentes, Libia M Lugo, Susan T Hadman, Demario L Walls
Investigators
FDA investigators tied to this site in the record.
Seneca D Toms4 insp.
Scott T Ballard2 insp.
Christopher J Adams2 insp.
Rebecca Rodriguez2 insp.
Jason F Chancey2 insp.
Veronica Fuentes1 insp.
Libia M Lugo1 insp.
Susan T Hadman1 insp.
Demario L Walls1 insp.
Fabian N Chaparro-Rodriguez1 insp.
Steven M Weinman1 insp.
Sonya M Edmonds1 insp.
Robert D Tollefsen1 insp.
Larry K Hampton1 insp.
Viviana Matta1 insp.
Lesley K Satterwhite1 insp.
Penny H Mccarver1 insp.
Cynthia Jim1 insp.
Gabriel R Mclemore1 insp.
Eileen J Bannerman1 insp.
Thomas R Berry1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.110(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.46(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(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 Baxter Healthcare Corporation'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