Company
United StatesCatalent Indiana, LLC, Bloomington, IN – FDA Inspections
Inspection records and compliance data for Catalent Indiana, LLC in Bloomington, Indiana. 16 FDA inspections on record (1 OAI), 7 Form 483s, 1 warning letter, last inspected April 24, 2026.
Company Profile
This profile covers Catalent Indiana, LLC based in Bloomington, Indiana, United States.
FDA Inspection History
- FDA inspections
- 16
- OAI
- 1
- VAI
- 7
- NAI
- 4
- Unclassified
- 4
- Form 483s
- 7
- Warning letters
- 1
First inspected December 15, 2011. Last inspected April 24, 2026.
Most cited issue areas
- Procedures not in writing, fully followed2 inspections
- Control procedures to monitor and validate performance1 inspection
- Investigations of discrepancies, failures1 inspection
FDA inspections (16)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 24, 2026 | Not classified | Human Drugs | 1317904 |
| July 14, 2025 | OAI | Human Drugs · Drug Quality Assurance | 1264264 |
| November 15, 2023 | VAI | Biologics, Human Drugs · Vaccines and Allergenic Products | 1224264 |
| May 12, 2023 | Not classified | Human Drugs | 1208718 |
| September 1, 2022 | VAI | Human Drugs · Drug Quality Assurance | 1178819 |
| October 18, 2019 | VAI | Human Drugs · Drug Quality Assurance | 1111350 |
| August 3, 2018 | NAI | Biologics · Blood and Blood Products | 1063669 |
| May 1, 2018 | Not classified | Human Drugs | 1053499 |
| January 19, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1040034 |
| May 19, 2017 | VAI | Human Drugs, Medical Devices & Rad Health · Drug Quality Assurance | 1030478 |
| February 17, 2017 | Not classified | Human Drugs | 1000371 |
| August 24, 2016 | VAI | Biologics · Blood and Blood Products | 991585 |
| November 7, 2014 | NAI | Human Drugs · Drug Quality Assurance | 903362 |
| October 25, 2013 | VAI | Human Drugs · Drug Quality Assurance | 855186 |
| June 17, 2013 | NAI | Human Drugs · Drug Quality Assurance | 836295 |
| December 15, 2011 | NAI | Medical Devices & Rad Health · Compliance: Devices | 759064 |
FDA documents
Form 483s (12)
Warning Letters (1)
Other regulators (1)
- Health Canada · 7 inspections · last October 31, 2023
People (6)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Catalent Indiana, LLC
FEI Number
3005949964
Address
1300 S Patterson Dr, Bloomington, Indiana 47403, United States
Country
United States
ID: 3422c8c4-978a-45ba-962b-b00002fffd6d