Overview
- 3 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2026-03-26.
At a glance
Inspections
3
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 25 Mar 2026 – 26 Mar 2026 | Biologics | 483 | View 483 → |
| 27 Jul 2023 | Biologics | Clean | |
| 30 Jul 2018 – 1 Aug 2018 | Biologics | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
26 Mar 2026
21 CFR 1271.160(b)(1)
Ensuring appropriate core requirements followed
Cited by Creighton T Tuzon, James A Banks
26 Mar 2026
21 CFR 1271.190(d)(1)
Procedures for cleaning, sanitation
Cited by Creighton T Tuzon, James A Banks
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 1271.160(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.190(d)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.200(d) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Elevate Surgical's 1 Form 483
Source PDFs 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