Overview
- 5 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2026-02-23.
At a glance
Inspections
5
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 11 Feb 2026 – 23 Feb 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 17 Nov 2022 | Medical Devices & Rad Health | Clean | |
| 1 Aug 2019 – 8 Aug 2019 | Medical Devices & Rad Health | Clean | |
| 19 Feb 2015 – 27 Feb 2015 | Medical Devices & Rad Health | Clean | |
| 27 Jul 2011 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
23 Feb 2026
ISO 13485:2016 Clause 5.4.2(b)
Integrity of the QMS not maintained
Cited by Albert L Nguyen
23 Feb 2026
ISO 13485:2016 Clause 7.3.7
Design and development validation not complete prior to release of product
Cited by Albert L Nguyen
23 Feb 2026
ISO 13485:2016 Clause 8.2.6
Product release and delivery proceeded prior to planned agreements completed
Cited by Albert L Nguyen
23 Feb 2026
ISO 13485:2016 Clause 8.5.2
Corrective action procedures not documented
Cited by Albert L Nguyen
Investigators
FDA investigators tied to this site in the record.
Albert L Nguyen1 insp.
Benjamin W Anderson1 insp.
Yehualashet A Gessesse1 insp.
Kyle J Mccracken1 insp.
Ralph W Jerndal1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| ISO 13485:2016 Clause 5.4.2(b) | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.3.7 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.2.6 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.5.2 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind SurgiSmoke Solutions' 1 Form 483
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