Catalent Indiana, LLC
Form 483 issued July 14, 2025 · Bloomington, Indiana
- Inspection
- Jun 23 – Jul 14, 2025
- Investigators
- Joohi Castelvetere· Martin M. Kimani· Robert J. Ham
- Observations
- 6
- Pages
- 22
- FEI number
- 3005949964
In short: On July 14, 2025, FDA issued a Form 483 with 6 observations to Catalent Indiana, LLC in Bloomington, Indiana (FEI 3005949964) after an inspection that ran Jun 23 – Jul 14, 2025. The investigators were Joohi Castelvetere, Martin M. Kimani, Robert J. Ham and Shannon L. Maisano. Most observations concern quality system and production.
At a glance
Quality system and production account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written records of investigations into the failure of a batch or any of its components to…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 03
Aseptic processing areas ai·e deficient regai·ding the system…
- 04
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
This inspection in context
Joohi Castelvetere
9 documents · 2024–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Indiana.
The firmCatalent Indiana, LLC history
All 10 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Catalent Indiana, LLC?
FDA listed 6 observations on this Form 483, mostly about quality system, production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Catalent Indiana, LLC?
Joohi Castelvetere, Martin M. Kimani, Robert J. Ham and Shannon L. Maisano are named on this Form 483, for the inspection of Jun 23 – Jul 14, 2025. Each investigator has a profile showing what they cite most.
When was Catalent Indiana, LLC inspected by FDA?
The inspection ran Jun 23 – Jul 14, 2025, and the Form 483 is dated July 14, 2025.
How do I get the full Form 483 for Catalent Indiana, LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.