Overview
- 4 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-01-31.
At a glance
Inspections
4
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 23 Jan 2025 – 31 Jan 2025 | Human Drugs | 483 | View 483 → |
| 10 Sep 2019 – 17 Sep 2019 | Human Drugs | 483 | View 483 → |
| 27 Jul 2015 – 30 Jul 2015 | Medical Devices & Rad Health | Clean | |
| 8 Apr 2010 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
31 Jan 2025
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Michael A Charles, Ana-Maria A Plapcianu
31 Jan 2025
21 CFR 211.192
Written record of investigation incomplete
Cited by Michael A Charles, Ana-Maria A Plapcianu
31 Jan 2025
21 CFR 211.80(b)
Handling and Storage to Prevent Contamination
Cited by Michael A Charles, Ana-Maria A Plapcianu
31 Jan 2025
21 CFR 211.84(d)(2)
Component identification test
Cited by Michael A Charles, Ana-Maria A Plapcianu
Investigators
FDA investigators tied to this site in the record.
Michael A Charles1 insp.
Ana-Maria A Plapcianu1 insp.
Alice S Tsao1 insp.
Yehualashe A Gessesse1 insp.
Frank J Marciniak1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 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 211.142(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Baxter Corporation's 2 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