Overview
- 5 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2023-10-18.
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 Oct 2023 – 18 Oct 2023 | Medical Devices & Rad Health | Clean | |
| 6 Jun 2016 – 22 Jun 2016 | Medical Devices & Rad Health | Clean | |
| 4 Oct 2012 | Not recorded | 483 | View 483 → |
| 16 Oct 2007 | Not recorded | Clean | |
| 8 Dec 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
4 Oct 2012
21 CFR 803.17(a)(3)
Lack of System for Timely Submission of Reports
Cited by Joshua J Silvestri
4 Oct 2012
21 CFR 820.30(g)
Design Validation - Risk analysis not performed/inadequate
Cited by Joshua J Silvestri
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 803.17(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind SRI Healthcare dba NOVO Health Services' 1 Form 483
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