FDA-Inspected Site

Baxter Healthcare Corporation

16 FDA inspections are on record for Baxter Healthcare Corporation in Cleveland, United States.

483· Form 483 issued

Cleveland, United States · Last updated August 15, 2026

Overview

  • 16 FDA inspections are on record.
  • 5 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-09-29.

At a glance

Inspections

16

Form 483s

5

EIRs

6

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
22 Sep 2025 – 29 Sep 2025Human Drugs483View 483 →
10 Jul 2023 – 14 Jul 2023Medical Devices & Rad HealthClean
14 Nov 2018 – 20 Nov 2018Human Drugs483View 483 →
27 Mar 2017 – 29 Mar 2017Human DrugsClean
25 Apr 2016 – 27 Apr 2016Medical Devices & Rad HealthClean
24 Mar 2015 – 27 Mar 2015Human DrugsClean
18 Nov 2014 – 21 Nov 2014Medical Devices & Rad HealthClean
7 Jan 2014 – 23 Jan 2014Animal Drugs & Feeds483View 483 →
5 Aug 2013 – 9 Aug 2013Medical Devices & Rad HealthClean
4 Mar 2013 – 6 Mar 2013Human DrugsClean
27 Jun 2012Not recorded483View 483 →
22 Oct 2010Not recordedClean

Observations on record

Form 483 observations cited at this site, most recent first.

29 Sep 2025
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Camerson E Moore

29 Sep 2025
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Camerson E Moore

29 Sep 2025
21 CFR 211.58

Buildings not maintained in good state of repair

Cited by Camerson E Moore

29 Sep 2025
21 CFR 211.67(a)

Cleaning / Sanitizing / Maintenance

Cited by Camerson E Moore

29 Sep 2025
21 CFR 211.68(b)

Backup data not assured as exact and complete

Cited by Camerson E Moore

Investigators

FDA investigators tied to this site in the record.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.110(a)Cited across public-safe Form 483 observations3x
21 CFR 211.100(b)Cited across public-safe Form 483 observations2x
21 CFR 211.22(a)Cited across public-safe Form 483 observations2x
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.165(d)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.22(c)Cited across public-safe Form 483 observations1x
21 CFR 211.58Cited across public-safe Form 483 observations1x
21 CFR 211.67(a)Cited across public-safe Form 483 observations1x
21 CFR 211.67(c)Cited across public-safe Form 483 observations1x
21 CFR 211.68(a)Cited across public-safe Form 483 observations1x
21 CFR 211.68(b)Cited across public-safe Form 483 observations1x
21 CFR 211.84(d)(2)Cited across public-safe Form 483 observations1x
21 CFR 820.90(a)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Baxter Healthcare Corporation's 5 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