Atlas

FDA-Inspected Site

Vivax Medical Corp.

6 FDA inspections are on record for Vivax Medical Corp. in Naugatuck, United States.

Clean· No action indicated

Naugatuck, United States · Last updated August 15, 2026

Overview

  • 6 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2024-04-17.

At a glance

Inspections

6

Form 483s

2

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
17 Apr 2024Medical Devices & Rad HealthClean
7 Jan 2020 – 8 Jan 2020Medical Devices & Rad HealthClean
13 Jul 2017 – 14 Jul 2017Medical Devices & Rad HealthClean
20 Mar 2014 – 26 Mar 2014Medical Devices & Rad Health483View 483 →
11 Aug 2011Not recorded483View 483 →
23 Nov 2005Not recordedClean

Observations on record

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

26 Mar 2014
21 CFR 803.17

Lack of Written MDR Procedures

Cited by Michael G Mayfield

26 Mar 2014
21 CFR 820.20(c)

Management review - Lack of or inadequate procedures

Cited by Michael G Mayfield

26 Mar 2014
21 CFR 820.30(a)

Design control - no procedures

Cited by Michael G Mayfield

26 Mar 2014
21 CFR 820.30(i)

Design changes - Lack of or Inadequate Procedures

Cited by Michael G Mayfield

26 Mar 2014
21 CFR 820.40

Procedures not adequately established or maintained

Cited by Michael G Mayfield

Investigators

FDA investigators tied to this site in the record.

Michael G Mayfield3 insp.
Katarzyna Plona1 insp.
Jeffrey J Thibodeau1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 803.17Cited across public-safe Form 483 observations1x
21 CFR 820.181Cited across public-safe Form 483 observations1x
21 CFR 820.186Cited across public-safe Form 483 observations1x
21 CFR 820.20(c)Cited across public-safe Form 483 observations1x
21 CFR 820.20(d)Cited across public-safe Form 483 observations1x
21 CFR 820.22Cited across public-safe Form 483 observations1x
21 CFR 820.30(a)Cited across public-safe Form 483 observations1x
21 CFR 820.30(i)Cited across public-safe Form 483 observations1x
21 CFR 820.40Cited across public-safe Form 483 observations1x
21 CFR 820.72(a)Cited across public-safe Form 483 observations1x
21 CFR 820.80(e)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Vivax Medical Corp.'s 2 Form 483s

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