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Facility profile

Catalent Indiana, LLC

Drug product manufacturing · Packaging & labeling · Bloomington, IN

FDA recordFDA directory updated Jul 21, 2026Profile not yet claimed2 registered company locations
Potential fit

Listed operations

The U.S. Food and Drug Administration (FDA) record lists broad activities for this site. Confirm specific services and availability directly.

LabelManufacturePack
Due diligence

Regulatory record at a glance

Use these records to guide qualification; they are not a facility score.

Registration record
Current FDA registration record

Expires Dec 31, 2026 · checked Jul 21, 2026

Latest matched inspection
Official action indicated (OAI)

Jul 14, 2025 · The findings may warrant official FDA action.

Matched compliance actions
Warning Letter · Nov 2025

Within five years · review the action and follow-up.

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Shows

Registration status and a latest matched official action indicated inspection.

Doesn’t show

Exact services, availability, capacity, pricing, or overall quality.

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Review the underlying findings, response, and subsequent follow-up before qualification.

Method and source details
View full inspection and compliance history14 inspection records

FDA inspection history

14 records, Dec 2011 – Jul 2025 · 4 NAI · 9 VAI · 1 OAI

DateClassProject areaCitationsFY
Jul 14, 2025OAIDrug Quality Assurance2025
Nov 15, 2023VAIVaccines and Allergenic Products2024
Nov 15, 2023VAIDrug Quality Assurance2024
Sep 1, 2022VAIDrug Quality Assurance2022
Oct 18, 2019VAIDrug Quality Assurance2020
Aug 3, 2018NAIBlood and Blood Products2018
Jan 19, 2018VAIDrug Quality Assurance2018
May 19, 2017VAICompliance: Devices2017
May 19, 2017VAIDrug Quality Assurance2017
Aug 24, 2016VAIBlood and Blood Products2016
Nov 7, 2014NAIDrug Quality Assurance2015
Oct 25, 2013VAIDrug Quality Assurance2014
Jun 17, 2013NAIDrug Quality Assurance2013
Dec 15, 2011NAICompliance: Devices2012

No action indicated (NAI) · Voluntary action indicated (VAI) · Official action indicated (OAI)

Matched compliance actions

Nov 21, 2025Warning Letter · CDER
Unclaimed profile

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