FDA-Inspected Site

Cirtec Medical Corp.

4 FDA inspections are on record for Cirtec Medical Corp. in Brooklyn Park, United States.

483· Form 483 issued

Brooklyn Park, United States · Last updated August 15, 2026

Overview

  • 4 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-01-13.

At a glance

Inspections

4

Form 483s

2

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
7 Jan 2026 – 13 Jan 2026Medical Devices & Rad Health483View 483 →
13 May 2025 – 15 May 2025Medical Devices & Rad Health483View 483 →
4 Sep 2024 – 6 Sep 2024Medical Devices & Rad HealthClean
18 Mar 2024 – 20 Mar 2024Medical Devices & Rad HealthClean

Observations on record

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

13 Jan 2026
21 CFR 820.75(a)

Lack of or inadequate process validation

Cited by Tyler R Courtney

15 May 2025
21 CFR 820.75(a)

Lack of or inadequate process validation

Cited by Tyler R Courtney

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 820.75(a)Cited across public-safe Form 483 observations2x

Full site report

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

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