FDA-Inspected Site

Digital Diagnostics Inc.

2 FDA inspections are on record for Digital Diagnostics Inc. in Coralville, United States.

Clean· No action indicated

Coralville, United States · Last updated August 15, 2026

Overview

  • 2 FDA inspections are on record.
  • 1 inspection produced a Form 483.
  • The most recent recorded inspection date is 2026-03-20.

At a glance

Inspections

2

Form 483s

1

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
17 Mar 2026 – 20 Mar 2026Medical Devices & Rad HealthClean
7 Nov 2022 – 10 Nov 2022Medical Devices & Rad Health483View 483 →

Observations on record

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

10 Nov 2022
21 CFR 806.20(a)

Records not kept

Cited by Nicholas Z Lu, Clifford F Long

10 Nov 2022
21 CFR 806.20(a)

Records not kept

Cited by Nicholas Z Lu, Clifford F Long

10 Nov 2022
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Nicholas Z Lu, Clifford F Long

10 Nov 2022
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Nicholas Z Lu, Clifford F Long

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 806.20(a)Cited across public-safe Form 483 observations2x
21 CFR 820.100(a)Cited across public-safe Form 483 observations2x

Full site report

Get the verbatim findings behind Digital Diagnostics Inc.'s 1 Form 483

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