Overview
- 38 FDA inspections are on record.
- 13 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-04-02.
At a glance
Inspections
38
Form 483s
13
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 23 Mar 2026 – 2 Apr 2026 | Human Drugs | 483 | View 483 → |
| 17 Nov 2025 – 25 Nov 2025 | Biologics | 483 | View 483 → |
| 23 Jul 2024 – 1 Aug 2024 | Human Drugs | 483 | On file |
| 14 Aug 2023 – 18 Aug 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 14 Aug 2023 | Medical Devices & Rad Health | Clean | |
| 24 Sep 2018 – 26 Sep 2018 | Medical Devices & Rad Health | Clean | |
| 14 Jun 2017 – 14 Jul 2017 | Biologics | 483 | On file |
| 27 Feb 2017 – 8 Mar 2017 | Human Drugs | Clean | |
| 14 Dec 2016 – 15 Dec 2016 | Medical Devices & Rad Health | Clean | |
| 30 Jun 2015 – 7 Jul 2015 | Human Drugs | WL | On file |
| 27 May 2015 – 19 Jun 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 10 Sep 2013 – 17 Sep 2013 | Biologics | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
2 Apr 2026
21 CFR 211.100(b)
Procedure Deviations Recorded and Justified
Cited by Robert J Ham, Logan T Williams, Paranthaman SenthamaraiKannan, Supreet K Sran
2 Apr 2026
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Robert J Ham, Logan T Williams, Paranthaman SenthamaraiKannan, Supreet K Sran
2 Apr 2026
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by Robert J Ham, Logan T Williams, Paranthaman SenthamaraiKannan, Supreet K Sran
2 Apr 2026
21 CFR 211.165(d)
Acceptance/Rejection Levels
Cited by Robert J Ham, Logan T Williams, Paranthaman SenthamaraiKannan, Supreet K Sran
2 Apr 2026
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Robert J Ham, Logan T Williams, Paranthaman SenthamaraiKannan, Supreet K Sran
Investigators
FDA investigators tied to this site in the record.
Russell K Riley4 insp.
Christopher D Leach3 insp.
Brian D Nicholson3 insp.
Nicholas Z Lu2 insp.
Jesse A Vazquez2 insp.
Sean T Creighton2 insp.
Robert J Ham1 insp.
Logan T Williams1 insp.
Supreet K Sran1 insp.
Shafiq Ahadi1 insp.
Peng Zhou1 insp.
Lisa L Flores1 insp.
Chad W Rice1 insp.
Monica E Murie1 insp.
Kyran R Gibson1 insp.
Denise L Burosh1 insp.
Jacqueline M Diaz Albert1 insp.
Michele L Glendenning1 insp.
That Q Dang1 insp.
Maksim A Levenchuk1 insp.
Simone E Pitts1 insp.
David J Gasparovich1 insp.
Burnell M Henry1 insp.
Prabhu P Raju1 insp.
Andrew A Leboeuf1 insp.
James W Plucinski1 insp.
Paola S Barnett1 insp.
Anthony F Lorenzo1 insp.
Gang Wang1 insp.
Margaret Torres-Vazquez1 insp.
Phung T Nguyen1 insp.
Stephen D Eich1 insp.
Rose M Ashley1 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 | 10x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 8x |
| 21 CFR 820.30(h) | Cited across public-safe Form 483 observations | 7x |
| 21 CFR 803.50(a)(2) | 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 211.25(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(b) | 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 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(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 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.94(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 803.17 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.250(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Baxter Healthcare Corporation's 13 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