Overview
- 5 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-04-16.
At a glance
Inspections
5
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 Apr 2026 – 16 Apr 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 1 Dec 2022 – 6 Dec 2022 | Medical Devices & Rad Health | Clean | |
| 20 Jan 2017 – 27 Jan 2017 | Medical Devices & Rad Health | Clean | |
| 7 Jun 2012 | Not recorded | 483 | View 483 → |
| 13 Nov 2008 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
16 Apr 2026
ISO 13485:2016 Clause 5.6.1
QMS not reviewed by top management at documented planned intervals
Cited by Amber M Capello-Jones
16 Apr 2026
ISO 13485:2016 Clause 6.3
Requirements for infrastructure maintenance activities not documented
Cited by Amber M Capello-Jones
7 Jun 2012
21 CFR 820.70(g)(1)
Maintenance schedule, Lack of or inadequate schedule
Cited by Christine E Kelley
Investigators
FDA investigators tied to this site in the record.
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 | 1x |
| 21 CFR 820.70(g)(1) | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 5.6.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 6.3 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind SRI Healthcare, Llc's 2 Form 483s
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