FDA-Inspected Site

Strukmyer Medical

6 FDA inspections are on record for Strukmyer Medical in Mesquite, United States.

Clean· No action indicated

Mesquite, United States · Last updated July 10, 2026

Overview

  • 6 FDA inspections are on record.
  • 3 inspections produced a Form 483.
  • The most recent recorded inspection date is 2024-09-06.

At a glance

Inspections

6

Form 483s

3

EIRs

1

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
4 Sep 2024 – 6 Sep 2024Medical Devices & Rad HealthClean
8 Jul 2024 – 1 Aug 2024Human DrugsWLOn file
21 Jul 2021 – 27 Jul 2021Medical Devices & Rad Health483On file
22 May 2018 – 25 May 2018Medical Devices & Rad Health483View 483 →
24 Mar 2014 – 28 Mar 2014Medical Devices & Rad HealthClean
31 Aug 2005Not recordedClean

Observations on record

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

25 May 2018
21 CFR 820.30(g)

Design Validation - Risk analysis not performed/inadequate

Cited by Roy Baby

25 May 2018
21 CFR 820.30(g)

Design Validation - Risk analysis not performed/inadequate

Cited by Roy Baby

Investigators

FDA investigators tied to this site in the record.

State Agency1 insp.
Roy Baby1 insp.
CntrctMntr YoungJD1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 820.30(g)Cited across public-safe Form 483 observations2x

Full site report

Get the verbatim findings behind Strukmyer Medical's 3 Form 483s

Source PDFs, 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