FDA-Inspected Site

Ventec Life Systems, Inc.

4 FDA inspections are on record for Ventec Life Systems, Inc. in Bothell, United States.

483· Form 483 issued

Bothell, United States · Last updated July 10, 2026

Overview

  • 4 FDA inspections are on record.
  • 3 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-12-17.

At a glance

Inspections

4

Form 483s

3

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
10 Dec 2025 – 17 Dec 2025Medical Devices & Rad Health483View 483 →
14 Jul 2022 – 27 Jul 2022Medical Devices & Rad Health483View 483 →
22 Mar 2021 – 12 May 2021Medical Devices & Rad Health483View 483 →
31 Jan 2019 – 7 Feb 2019Medical Devices & Rad HealthClean

Observations on record

Form 483 observations cited at this site, most recent first.

17 Dec 2025
21 CFR 820.184

DHR content

Cited by Brian R Hendricks

17 Dec 2025
21 CFR 820.184

DHR content

Cited by Brian R Hendricks

17 Dec 2025
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Brian R Hendricks

17 Dec 2025
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Brian R Hendricks

27 Jul 2022
21 CFR 803.50(a)(2)

Individual Report of Malfunction

Cited by Stephen R Souza

Investigators

FDA investigators tied to this site in the record.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 803.50(a)(2)Cited across public-safe Form 483 observations4x
21 CFR 820.184Cited across public-safe Form 483 observations2x
21 CFR 820.198(a)Cited across public-safe Form 483 observations2x
21 CFR 803.17(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 820.100(a)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Ventec Life Systems, Inc.'s 3 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