Overview
- 5 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2019-09-17.
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 |
|---|---|---|---|
| 17 Sep 2019 | Biologics | Clean | |
| 3 Nov 2016 – 4 Nov 2016 | Biologics | Clean | |
| 9 Oct 2014 – 10 Oct 2014 | Biologics | 483 | View 483 → |
| 3 Jan 2013 | Not recorded | Clean | |
| 21 Jan 2011 | 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.
Shelley H Beausoleil1 insp.
Laverne Puckett1 insp.
Roger D Gawne1 insp.
Jennifer H Rhyu1 insp.
Aneel K Sandhu1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.160(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Focus Surgical Inc'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