Catalent Indiana, LLC
FDA inspection history in Bloomington, Indiana, 2017 to 2026
- 9
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2017: one Form 483; 2018: one Form 483; 2019: one Form 483; 2020: one Form 483; 2022: one Form 483; 2023: two Form 483s; 2025: one warning letter and one Form 483; 2026: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017–26Nine Form 483s and one warning letter, at Bloomington, Indiana.
- 2025The longest 483 on file: 6 observations over 22 pages at Bloomington, Indiana.
Cited most
Across all Catalent Indiana observations on file
- 21 CFR 211.113Control of microbiological contamination7
- 21 CFR 211.192Production record review5
- 21 CFR 211.100Written procedures; deviations4
- 21 CFR 211.22Responsibilities of quality control unit4
- 21 CFR 211.67Equipment cleaning and maintenance4
The complete Catalent Indiana file.
All 10 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
25% off buying them one by one
Sites
Bloomington, Indiana
Nine Form 483s and one warning letter · 2017 to 2026 · 38 observations
Latest: Form 483, Apr 24, 2026 →
Documents
10 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-04-24 | 483 Form 483 | Bloomington, Indiana | 1 | $99 |
| 2025-11-20 | Warning letter Warning letter | Bloomington, Indiana | — | $99 |
| 2025-07-14 | 483 Form 483 | Bloomington, Indiana | 6 | $99 |
| 2023-11-15 | 483 Form 483 | Bloomington, Indiana | 6 | $99 |
| 2023-05-12 | 483 Form 483 | Bloomington, Indiana | 3 | $99 |
| 2022-09-01 | 483 Form 483 | Bloomington, Indiana | 6 | $99 |
| 2020-09-02 | 483 Form 483 | Bloomington, Indiana | 1 | $99 |
| 2019-10-18 | 483 Form 483 | Bloomington, Indiana | 5 | $99 |
| 2018-05-01 | 483 Form 483 | Bloomington, Indiana | 4 | $99 |
| 2017-05-19 | 483 Form 483 | Bloomington, Indiana | 6 | $99 |
Investigators on these documents
Robert J. Ham (2)Joohi Castelvetere (2)Cristina Ausin-Moreno (1)Eboni Funderburk (1)Esther C. Broner (1)Hyung-Yul Lee (1)Jacob G. Lutz (1)Jon P. Antoniou (1)Logan T. Williams (1)Martin M. Kimani (1)Michael R. Shanks (1)Michele Perry Williams (1)
FEI number 3005949964 · most recent document Apr 24, 2026
About Catalent Indiana, LLC
How many FDA Form 483s has Catalent Indiana, LLC received?
FDA Intel has 9 Form 483s on file for Catalent Indiana, LLC; the most recent is dated Apr 24, 2026.
When was Catalent Indiana, LLC last inspected by FDA?
The most recent FDA inspection document on file for Catalent Indiana, LLC is a Form 483 dated Apr 24, 2026, for the site in Bloomington, Indiana.
What did FDA cite at Catalent Indiana, LLC?
The regulations cited most in the observations on file for Catalent Indiana, LLC are 21 CFR 211.113 (Control of microbiological contamination), 7 times; 21 CFR 211.192 (Production record review), 5 times; 21 CFR 211.100 (Written procedures; deviations), 4 times.
Has Catalent Indiana, LLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Catalent Indiana, LLC; the most recent is dated Nov 20, 2025.