FDA-Inspected Site

Clear Guide Medical, Inc.

3 FDA inspections are on record for Clear Guide Medical, Inc. in Baltimore, United States.

Clean· No action indicated

Baltimore, United States · Last updated July 10, 2026

Overview

  • 3 FDA inspections are on record.
  • 1 inspection produced a Form 483.
  • The most recent recorded inspection date is 2026-05-15.

At a glance

Inspections

3

Form 483s

1

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
12 May 2026 – 15 May 2026Medical Devices & Rad HealthClean
6 Nov 2019 – 13 Nov 2019Medical Devices & Rad Health483View 483 →
13 Oct 2015 – 14 Oct 2015Medical Devices & Rad HealthClean

Observations on record

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

13 Nov 2019
21 CFR 820.22

Quality audits - Lack of or inadequate procedures

Cited by Jude C Dike

13 Nov 2019
21 CFR 820.22

Quality audits - Lack of or inadequate procedures

Cited by Jude C Dike

13 Nov 2019
21 CFR 820.30(e)

Design review - Lack of or inadequate procedures

Cited by Jude C Dike

13 Nov 2019
21 CFR 820.30(e)

Design review - Lack of or inadequate procedures

Cited by Jude C Dike

13 Nov 2019
21 CFR 820.50

Purchasing controls, Lack of or inadequate procedures

Cited by Jude C Dike

Investigators

FDA investigators tied to this site in the record.

Andrea D Gomez1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 820.22Cited across public-safe Form 483 observations4x
21 CFR 820.30(e)Cited across public-safe Form 483 observations4x
21 CFR 820.50Cited across public-safe Form 483 observations4x
21 CFR 820.70(i)Cited across public-safe Form 483 observations4x

Full site report

Get the verbatim findings behind Clear Guide Medical, Inc.'s 1 Form 483

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