Atlas

FDA-Inspected Site

Catalent Indiana, LLC

19 FDA inspections are on record for Catalent Indiana, LLC in Bloomington, United States.

483· Form 483 issued

Bloomington, United States · Last updated July 9, 2026

Overview

  • 19 FDA inspections are on record.
  • 13 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-04-24.

At a glance

Inspections

19

Form 483s

13

EIRs

11

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
13 Apr 2026 – 24 Apr 2026Human Drugs483On file
23 Jun 2025 – 14 Jul 2025Human DrugsWLOn file
31 Oct 2023 – 15 Nov 2023Biologics483View 483 →
4 May 2023 – 12 May 2023Human Drugs483On file
1 Aug 2022 – 1 Sep 2022Human Drugs483On file
27 Aug 2020 – 2 Sep 2020Human Drugs483On file
7 Oct 2019 – 18 Oct 2019Human Drugs483On file
31 Jul 2018 – 3 Aug 2018BiologicsClean
23 Apr 2018 – 1 May 2018Human Drugs483On file
16 Jan 2018 – 19 Jan 2018Human DrugsClean
15 May 2017 – 19 May 2017Medical Devices & Rad Health483View 483 →
13 Feb 2017 – 17 Feb 2017Human Drugs483On file

Observations on record

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

15 Nov 2023
21 CFR 211.110(a)

Control procedures to monitor and validate performance

Cited by Andrew J Barrowcliff, Wendy G Tan, Alan L Truong, Rafeeq A Habeeb, Jacob G Lutz, Charles Y Kuo

15 Nov 2023
21 CFR 211.110(a)

Control procedures to monitor and validate performance

Cited by Andrew J Barrowcliff, Wendy G Tan, Alan L Truong, Rafeeq A Habeeb, Jacob G Lutz, Charles Y Kuo

15 Nov 2023
21 CFR 211.110(a)

Control procedures to monitor and validate performance

Cited by Andrew J Barrowcliff, Wendy G Tan, Alan L Truong, Rafeeq A Habeeb, Jacob G Lutz, Charles Y Kuo

15 Nov 2023
21 CFR 211.113(b)

Validation lacking for sterile drug products

Cited by Andrew J Barrowcliff, Wendy G Tan, Alan L Truong, Rafeeq A Habeeb, Jacob G Lutz, Charles Y Kuo

15 Nov 2023
21 CFR 211.113(b)

Validation lacking for sterile drug products

Cited by Andrew J Barrowcliff, Wendy G Tan, Alan L Truong, Rafeeq A Habeeb, Jacob G Lutz, Charles Y Kuo

Investigators

FDA investigators tied to this site in the record.

Robert M Barbosa5 insp.
Robert J Ham2 insp.
Joohi Castelvetere2 insp.
Wayne E Seifert2 insp.
Michele L Forster2 insp.
Brandy N Lepage1 insp.
Martin M Kimani1 insp.
Shannon L Maisano1 insp.
Andrew J Barrowcliff1 insp.
Wendy G Tan1 insp.
Alan L Truong1 insp.
Rafeeq A Habeeb1 insp.
Jacob G Lutz1 insp.
Charles Y Kuo1 insp.
Sandra A Boyd1 insp.
Logan T Williams1 insp.
Muna Algharibeh1 insp.
Eboni S Funderburk1 insp.
Michael Shanks1 insp.
Michele Perry-Williams1 insp.
Jon P Antoniou1 insp.
Vaishali J Patel1 insp.
Timothy J Schmidt1 insp.
Nicholas L Paulin1 insp.
Scott R Nichols1 insp.
Emilie Kahn1 insp.
Sargum C Sood1 insp.
Jeffrey D Meng1 insp.
Diane L Raccasi1 insp.
Maria I Cruz-Fisher1 insp.
Edwin Jao1 insp.
Meisha R Sampson1 insp.
Sneha S Patel1 insp.
Rabia Ballica1 insp.
Sean R Byrd1 insp.
James A Lane1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.22(d)Cited across public-safe Form 483 observations7x
21 CFR 211.100(b)Cited across public-safe Form 483 observations3x
21 CFR 211.110(a)Cited across public-safe Form 483 observations3x
21 CFR 211.113(b)Cited across public-safe Form 483 observations3x
21 CFR 211.160(b)Cited across public-safe Form 483 observations3x
21 CFR 211.192Cited across public-safe Form 483 observations3x
21 CFR 211.67(b)Cited across public-safe Form 483 observations3x
21 CFR 820.100(a)Cited across public-safe Form 483 observations3x
21 CFR 820.50Cited across public-safe Form 483 observations3x
21 CFR 820.70(a)Cited across public-safe Form 483 observations3x
21 CFR 820.75(a)Cited across public-safe Form 483 observations3x

Full site report

Get the verbatim findings behind Catalent Indiana, LLC's 13 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