Overview
- 8 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2017-06-23.
At a glance
Inspections
8
Form 483s
5
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 19 Jun 2017 – 23 Jun 2017 | Medical Devices & Rad Health | Clean | |
| 6 Jul 2016 – 8 Jul 2016 | Medical Devices & Rad Health | 483 | On file |
| 21 Oct 2013 – 10 Dec 2013 | Medical Devices & Rad Health | Clean | |
| 31 Oct 2012 | Not recorded | 483 | View 483 → |
| 19 Nov 2010 | Not recorded | 483 | View 483 → |
| 12 May 2008 | Not recorded | 483 | On file |
| 14 Jan 2008 | Not recorded | 483 | On file |
| 25 Nov 2003 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
31 Oct 2012
21 CFR 820.30(f)
Design verification - output does not meet input requirement
Cited by Kimberly M Lichter, Trudy R Papson
31 Oct 2012
21 CFR 820.30(g)
Design validation - production units
Cited by Kimberly M Lichter, Trudy R Papson
Investigators
FDA investigators tied to this site in the record.
MDSAP WilliamsA2 insp.
Kimberly M Lichter2 insp.
Trudy R Papson2 insp.
Kirtida Patel2 insp.
Deborah A Greco1 insp.
Gene D Arcy1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.50(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 806.10(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Halyard - Irvine'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