Overview
- 12 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2021-09-23.
At a glance
Inspections
12
Form 483s
5
EIRs
1
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 7 Sep 2021 – 23 Sep 2021 | Medical Devices & Rad Health | Clean | |
| 17 Oct 2018 – 19 Oct 2018 | Medical Devices & Rad Health | Clean | |
| 25 Apr 2017 – 28 Apr 2017 | Medical Devices & Rad Health | Clean | |
| 9 Apr 2015 – 24 Apr 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 16 Oct 2014 – 19 Nov 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 8 Nov 2012 | Not recorded | Clean | |
| 26 Jan 2012 | Not recorded | 483 | View 483 → |
| 26 May 2010 | Not recorded | 483 | On file |
| 28 Jan 2008 | Not recorded | Clean | |
| 29 Mar 2007 | Not recorded | Clean | |
| 3 Jan 2006 | Not recorded | Clean | |
| 15 Feb 2005 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
24 Apr 2015
21 CFR 820.75(a)
Lack of or inadequate process validation
Cited by Brian S Keefer, Daniel W Johnson
24 Apr 2015
21 CFR 820.75(a)
Lack of or inadequate process validation
Cited by Brian S Keefer, Daniel W Johnson
19 Nov 2014
21 CFR 820.30(f)
Design verification acceptance criteria
Cited by Edward D Mcdonald, Daniel W Johnson
19 Nov 2014
21 CFR 820.30(h)
Design transfer - Lack of or inadequate procedures
Cited by Edward D Mcdonald, Daniel W Johnson
Investigators
FDA investigators tied to this site in the record.
Edward D Mcdonald3 insp.
Brian S Keefer3 insp.
Daniel W Johnson2 insp.
Michael J Nerz2 insp.
Jeen S Min1 insp.
Kristina J Donohue1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.184(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(h) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Custom Ultrasonics, Inc.'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