FDA-Inspected Site

Cardinal Health 414, LLC

5 FDA inspections are on record for Cardinal Health 414, LLC in Rochester, United States.

Clean· No action indicated

Rochester, United States · Last updated August 15, 2026

Overview

  • 5 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-08-29.

At a glance

Inspections

5

Form 483s

2

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
25 Aug 2025 – 29 Aug 2025Human DrugsClean
29 Jan 2019 – 1 Feb 2019Human DrugsClean
3 Feb 2015 – 5 Feb 2015Human DrugsClean
13 Sep 2012Not recorded483View 483 →
26 Jun 2008Not recorded483On file

Observations on record

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

13 Sep 2012
21 CFR 212.20(d)

Determination need for investigation

Cited by Paul C Mouris

13 Sep 2012
21 CFR 212.30(b)

Equipment not clean

Cited by Paul C Mouris

13 Sep 2012
21 CFR 212.40(a)

Suitable for intended use

Cited by Paul C Mouris

13 Sep 2012
21 CFR 212.50

Adequate controls (general)

Cited by Paul C Mouris

13 Sep 2012
21 CFR 212.60(g)(3)

Complete record of all laboratory test data

Cited by Paul C Mouris

Investigators

FDA investigators tied to this site in the record.

James D Bridges1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 212.20(d)Cited across public-safe Form 483 observations1x
21 CFR 212.30(b)Cited across public-safe Form 483 observations1x
21 CFR 212.40(a)Cited across public-safe Form 483 observations1x
21 CFR 212.50Cited across public-safe Form 483 observations1x
21 CFR 212.60(g)(3)Cited across public-safe Form 483 observations1x
21 CFR 212.70(e)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Cardinal Health 414, LLC's 2 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