FDA-Inspected Site

Cancer Diagnostics Inc.

3 FDA inspections are on record for Cancer Diagnostics Inc. in Durham, United States.

483· Form 483 issued

Durham, United States · Last updated August 15, 2026

Overview

  • 3 FDA inspections are on record.
  • 3 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-04-04.

At a glance

Inspections

3

Form 483s

3

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
2 Apr 2025 – 4 Apr 2025Medical Devices & Rad Health483View 483 →
12 Aug 2019 – 14 Aug 2019Medical Devices & Rad Health483View 483 →
9 Sep 2015 – 11 Sep 2015Medical Devices & Rad Health483On file

Observations on record

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

4 Apr 2025
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Jamie P Webb

4 Apr 2025
21 CFR 820.198(e)

Maintained

Cited by Jamie P Webb

4 Apr 2025
21 CFR 820.20(c)

Management review - Lack of or inadequate procedures

Cited by Jamie P Webb

4 Apr 2025
21 CFR 820.22

Quality audits - Lack of or inadequate procedures

Cited by Jamie P Webb

4 Apr 2025
21 CFR 820.30(a)

Design control - no procedures

Cited by Jamie P Webb

Investigators

FDA investigators tied to this site in the record.

Ernest H Blackwood1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 820.20(c)Cited across public-safe Form 483 observations5x
21 CFR 820.22Cited across public-safe Form 483 observations5x
21 CFR 820.30(a)Cited across public-safe Form 483 observations5x
21 CFR 820.250(a)Cited across public-safe Form 483 observations4x
21 CFR 820.50Cited across public-safe Form 483 observations3x
21 CFR 803.17(a)(1)Cited across public-safe Form 483 observations2x
21 CFR 820.100(a)Cited across public-safe Form 483 observations1x
21 CFR 820.198(e)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Cancer Diagnostics Inc.'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