Overview
- 5 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2021-10-27.
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 |
|---|---|---|---|
| 26 Oct 2021 – 27 Oct 2021 | Medical Devices & Rad Health | Clean | |
| 24 Oct 2018 – 30 Oct 2018 | Medical Devices & Rad Health | Clean | |
| 2 Aug 2017 – 3 Aug 2017 | Medical Devices & Rad Health | Clean | |
| 21 May 2013 – 24 May 2013 | Medical Devices & Rad Health | 483 | View 483 → |
| 15 Jun 2010 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
State Agency1 insp.
Juanita Banuelos1 insp.
CNTRMMNTR MAGEET1 insp.
James P Stallings1 insp.
Cntrctmntr Anderson1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Irhythm Technologies Inc Orange County'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