Overview
- 9 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-04-10.
At a glance
Inspections
9
Form 483s
6
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 3 Apr 2023 – 10 Apr 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 23 Jan 2017 – 3 Feb 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 31 Jul 2014 – 11 Aug 2014 | Medical Devices & Rad Health | WL | View 483 → |
| 2 May 2012 | Not recorded | Clean | |
| 15 Apr 2011 | Not recorded | WL | View 483 → |
| 12 Oct 2010 | Not recorded | 483 | On file |
| 9 Nov 2009 | Not recorded | 483 | View 483 → |
| 27 Sep 2006 | Not recorded | Clean | |
| 3 Jun 2004 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
10 Apr 2023
21 CFR 820.250(a)
Statistical techniques - Lack of or inadequate procedures
Cited by David J Gasparovich
10 Apr 2023
21 CFR 820.250(a)
Statistical techniques - Lack of or inadequate procedures
Cited by David J Gasparovich
Investigators
FDA investigators tied to this site in the record.
Brian P Putz3 insp.
Thomas A Peter2 insp.
David J Gasparovich1 insp.
Amy S Graf1 insp.
Cynthia L Aycock1 insp.
Cynthia Li1 insp.
Tracey L Siebesma1 insp.
Ryan J Benedict1 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 | 4x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.250(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 806.10(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(j) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.50(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.17(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.181 | Cited across public-safe Form 483 observations | 1x |
| 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 820.22 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(h) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(g)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.72(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Signal Medical Corporation's 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