Overview
- 5 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-03-24.
At a glance
Inspections
5
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 23 Mar 2026 – 24 Mar 2026 | Medical Devices & Rad Health | Clean | |
| 23 Jan 2023 – 26 Jan 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 7 Jan 2020 – 10 Jan 2020 | Medical Devices & Rad Health | 483 | View 483 → |
| 13 May 2013 – 14 May 2013 | Medical Devices & Rad Health | Clean | |
| 17 Jun 2010 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
26 Jan 2023
21 CFR 820.72(a)
Calibration, Inspection, etc. Procedures Lack of or Inadequ
Cited by Terri E Gibson
26 Jan 2023
21 CFR 820.72(a)
Calibration, Inspection, etc. Procedures Lack of or Inadequ
Cited by Terri E Gibson
10 Jan 2020
21 CFR 820.30(g)
Design Validation - Risk analysis not performed/inadequate
Cited by Eric J Heinze, Amogh Pathi
Investigators
FDA investigators tied to this site in the record.
Christopher W Buser1 insp.
Terri E Gibson1 insp.
Eric J Heinze1 insp.
Amogh Pathi1 insp.
Cynthia L Gorveatt1 insp.
Timothy C Grome1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.75(c) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind Avantec Vascular Corporation's 2 Form 483s
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