Overview
- 7 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-03-03.
At a glance
Inspections
7
Form 483s
6
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 24 Feb 2026 – 3 Mar 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 8 Feb 2022 – 24 Feb 2022 | Medical Devices & Rad Health | 483 | View 483 → |
| 6 Sep 2017 – 13 Sep 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 14 Nov 2016 – 1 Dec 2016 | Human Drugs | Clean | |
| 5 Oct 2015 – 16 Oct 2015 | Human Drugs | 483 | View 483 → |
| 13 May 2015 – 4 Jun 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 24 Jun 2011 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
3 Mar 2026
ISO 13485:2016 Clause 8.5.2
Corrective action procedures not documented
Cited by Melina L Rodriguez-Upton
24 Feb 2022
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Joseph R Strelnik, Robert M Barbosa
24 Feb 2022
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Joseph R Strelnik, Robert M Barbosa
24 Feb 2022
21 CFR 820.30(f)
Design verification - Lack of or inadequate procedures
Cited by Joseph R Strelnik, Robert M Barbosa
24 Feb 2022
21 CFR 820.30(f)
Design verification - Lack of or inadequate procedures
Cited by Joseph R Strelnik, Robert M Barbosa
Investigators
FDA investigators tied to this site in the record.
Robert M Barbosa3 insp.
Debara R Reese3 insp.
Joseph R Strelnik2 insp.
Melina L Rodriguez-Upton1 insp.
Robert J Ham1 insp.
Frank Wackes1 insp.
Patrick B Cummings1 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 | 7x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.70(c) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.80(c) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(g)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.5.2 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Kimball Electronics - Indianapolis' 6 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