Overview
- 13 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-03-26.
At a glance
Inspections
13
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 24 Mar 2025 – 26 Mar 2025 | Human Drugs | 483 | View 483 → |
| 9 Sep 2020 – 16 Sep 2020 | Animal Drugs & Feeds | Clean | |
| 15 Oct 2018 – 24 Oct 2018 | Human Drugs | 483 | View 483 → |
| 7 Dec 2016 – 13 Dec 2016 | Human Drugs | Clean | |
| 20 Jan 2015 – 6 Feb 2015 | Human Drugs | WL | View 483 → |
| 20 Nov 2013 – 4 Dec 2013 | Human Drugs | Clean | |
| 18 May 2012 | Not recorded | Clean | |
| 30 Jun 2011 | Not recorded | Clean | |
| 30 Sep 2010 | Not recorded | 483 | On file |
| 28 Aug 2008 | Not recorded | 483 | On file |
| 14 Nov 2005 | Not recorded | Clean | |
| 2 Jun 2004 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
26 Mar 2025
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Jose F Velez, Yoriann M Cabrera Bartolomei, Christian F Gomez Lugo
Investigators
FDA investigators tied to this site in the record.
Jose F Velez2 insp.
Vilmary Negron Rodriguez2 insp.
Libia M Lugo2 insp.
Laiza V Garcia2 insp.
Yoriann M Cabrera Bartolomei1 insp.
Christian F Gomez Lugo1 insp.
Ariel Cruz Figueroa1 insp.
Dayna I Martinez1 insp.
Brenda Rivera1 insp.
Noreen Muniz1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.188(b)(5) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Baxter Healthcare Corporation's 5 Form 483s
Source PDFs 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