FDA-Inspected Site

Catalent CTS, LLC

20 FDA inspections are on record for Catalent CTS, LLC in Kansas City, United States.

483· Form 483 issued

Kansas City, United States · Last updated July 9, 2026

Overview

  • 20 FDA inspections are on record.
  • 5 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-03-23.

At a glance

Inspections

20

Form 483s

5

EIRs

3

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
16 Mar 2026 – 23 Mar 2026Human Drugs483On file
28 Feb 2022 – 4 Mar 2022Human DrugsClean
15 Oct 2018 – 23 Oct 2018Human Drugs483On file
30 Oct 2017 – 6 Nov 2017Human DrugsClean
22 Jun 2015 – 29 Jun 2015Human DrugsClean
27 Oct 2014 – 10 Nov 2014Human Drugs483View 483 →
4 Mar 2014 – 5 Mar 2014Human DrugsClean
5 Sep 2013 – 10 Sep 2013Human DrugsClean
14 Jan 2013Not recordedClean
8 Jun 2012Not recordedClean
24 Mar 2010Not recorded483On file
4 Feb 2009Not recordedClean

Observations on record

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

10 Nov 2014
21 CFR 211.110(a)

Control procedures to monitor and validate performance

Cited by Victoria A Wagoner

10 Nov 2014
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Victoria A Wagoner

10 Nov 2014
21 CFR 211.186(b)(9)

Complete instructions, procedures, specifications et. al.

Cited by Victoria A Wagoner

10 Nov 2014
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Victoria A Wagoner

Investigators

FDA investigators tied to this site in the record.

Kelly M Bromley1 insp.
Gretchen L Trendel1 insp.
Carl J Montgomery1 insp.
Gwyn G Dickinson1 insp.
Michael S Smoker1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.110(a)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.186(b)(9)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Catalent CTS, LLC's 5 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