Overview
- 13 FDA inspections are on record.
- 9 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-04-12.
At a glance
Inspections
13
Form 483s
9
EIRs
1
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 8 Apr 2024 – 12 Apr 2024 | Medical Devices & Rad Health | Clean | |
| 15 Nov 2021 – 19 Nov 2021 | Medical Devices & Rad Health | 483 | View 483 → |
| 7 Nov 2017 – 10 Nov 2017 | Medical Devices & Rad Health | 483 | On file |
| 2 Dec 2014 – 19 Dec 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 9 Jan 2014 – 13 Feb 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 11 Jan 2013 | Not recorded | 483 | View 483 → |
| 11 Oct 2011 | Not recorded | WL | On file |
| 6 Jul 2010 | Not recorded | 483 | View 483 → |
| 23 Jan 2009 | Not recorded | 483 | On file |
| 21 Jun 2007 | Not recorded | WL | On file |
| 9 Sep 2004 | Not recorded | Clean | |
| 18 Sep 2001 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
19 Nov 2021
21 CFR 820.198(c)
Investigation of device failures
Cited by Joseph R Strelnik, Amber M Capello-Jones
19 Nov 2021
21 CFR 820.198(c)
Investigation of device failures
Cited by Joseph R Strelnik, Amber M Capello-Jones
19 Nov 2021
21 CFR 820.90(a)
Nonconforming product, Lack of or inadequate procedures
Cited by Joseph R Strelnik, Amber M Capello-Jones
19 Nov 2021
21 CFR 820.90(a)
Nonconforming product, Lack of or inadequate procedures
Cited by Joseph R Strelnik, Amber M Capello-Jones
Investigators
FDA investigators tied to this site in the record.
Joseph R Strelnik5 insp.
Patrick B Cummings4 insp.
Sean T Creighton3 insp.
David J Gasparovich1 insp.
Amber M Capello-Jones1 insp.
MDSAP WilliamsA1 insp.
Debara R Reese1 insp.
Charles M Spyr1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 803.17 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.60 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.86 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(b)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Hill-Rom Inc's 9 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