Overview
- 5 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2016-11-03.
At a glance
Inspections
5
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 31 Oct 2016 – 3 Nov 2016 | Medical Devices & Rad Health | Clean | |
| 11 Apr 2013 – 25 Apr 2013 | Medical Devices & Rad Health | Clean | |
| 22 Mar 2010 | Not recorded | 483 | View 483 → |
| 2 Mar 2009 | Not recorded | Clean | |
| 8 May 2008 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
22 Mar 2010
21 CFR 820.30(f)
Design verification - Lack of or inadequate procedures
Cited by Scott K Zika
22 Mar 2010
21 CFR 820.70(g)
Equipment Installation, Placement, Specified Requirements
Cited by Scott K Zika
Investigators
FDA investigators tied to this site in the record.
Cntrctmntr Anderson2 insp.
Jocelyn E Massey1 insp.
Vickie L Anderson1 insp.
Yvette M Lacour-Davis1 insp.
Scott K Zika1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.198(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(g) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Cardiac Science Corporation's 1 Form 483
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