Catalent Pharma Solutions, LLC
FDA inspection history across 2 sites, 2016 to 2026
- 5
- Form 483s
Every document, by year
- Form 483
2016: one Form 483; 2018: one Form 483; 2019: one Form 483; 2023: one Form 483; 2026: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016–19Three Form 483s, at Saint Petersburg, Florida and St Petersburg, Florida.
- 2016The longest 483 on file: 14 observations over 14 pages at Saint Petersburg, Florida.
- 2023One Form 483, at St Petersburg, Florida.
- 2026One Form 483, at Saint Petersburg, Florida.
Cited most
Across all Catalent Pharma Solutions observations on file
- 21 CFR 111.70(b)(1)What specifications must you establish?5
- 21 CFR 211.160General requirements4
- 21 CFR 211.100Written procedures; deviations3
- 21 CFR 211.22Responsibilities of quality control unit3
- 21 CFR 211.113Control of microbiological contamination2
The complete Catalent Pharma Solutions file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
St Petersburg, Florida
Three Form 483s · 2018 to 2023 · 15 observations
Latest: Form 483, Jul 21, 2023 →Saint Petersburg, Florida
Two Form 483s · 2016 to 2026 · 16 observations
Latest: Form 483, Jan 30, 2026 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-01-30 | 483 Form 483 | Saint Petersburg, Florida | 2 | $99 |
| 2023-07-21 | 483 Form 483 | St Petersburg, Florida | 8 | $99 |
| 2019-02-22 | 483 Form 483 | St Petersburg, Florida | 3 | $99 |
| 2018-06-14 | 483 Form 483 | St Petersburg, Florida | 4 | $99 |
| 2016-03-25 | 483 Form 483 | Saint Petersburg, Florida | 14 | $99 |
Investigators on these documents
Christos G. Tsingelis (1)Damaris Y. Hernandez (1)Ileana Barreto-Pettit (1)Jennifer Lalama (1)Jessica L. Pressley (1)Jogy George (1)Moraima J. Specs (1)Nicole E. Knowlton (1)Saleem A. Akhtar (1)Tammy T. Brown (1)
FEI number 1811396 · most recent document Jan 30, 2026
About Catalent Pharma Solutions, LLC
How many FDA Form 483s has Catalent Pharma Solutions, LLC received?
FDA Intel has 5 Form 483s on file for Catalent Pharma Solutions, LLC; the most recent is dated Jan 30, 2026.
When was Catalent Pharma Solutions, LLC last inspected by FDA?
The most recent FDA inspection document on file for Catalent Pharma Solutions, LLC is a Form 483 dated Jan 30, 2026, for the site in Saint Petersburg, Florida.
What did FDA cite at Catalent Pharma Solutions, LLC?
The regulations cited most in the observations on file for Catalent Pharma Solutions, LLC are 21 CFR 111.70(b)(1) (What specifications must you establish?), 5 times; 21 CFR 211.160 (General requirements), 4 times; 21 CFR 211.100 (Written procedures; deviations), 3 times.