Catalent Indiana, LLC
Form 483 issued April 24, 2026 · Bloomington, Indiana
- Inspection
- Apr 13 – Apr 24, 2026
- Investigators
- Brandy N. Lepage· Joohi Castelvetere· Robert J. Ham
- Observations
- 1
- Pages
- 15
- FEI number
- 3005949964
In short: On April 24, 2026, FDA issued a Form 483 with 1 observation to Catalent Indiana, LLC in Bloomington, Indiana (FEI 3005949964) after an inspection that ran Apr 13 – Apr 24, 2026. The investigators were Brandy N. Lepage, Joohi Castelvetere and Robert J. Ham. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×)
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…
This inspection in context
Brandy N. Lepage
31 documents · 2021–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Pennsylvania.
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 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Catalent Indiana, LLC?
Brandy N. Lepage, Joohi Castelvetere and Robert J. Ham are named on this Form 483, for the inspection of Apr 13 – Apr 24, 2026. Each investigator has a profile showing what they cite most.
When was Catalent Indiana, LLC inspected by FDA?
The inspection ran Apr 13 – Apr 24, 2026, and the Form 483 is dated April 24, 2026.
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.