Catalent Pharma Solutions, LLC
FDA inspection history in Winchester, Kentucky, 2023 to 2025
- 2
- Form 483s
Every document, by year
- Form 483
2023: one Form 483; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2023–25Two Form 483s, at Winchester, Kentucky.
- 2025The longest 483 on file: 4 observations over 26 pages at Winchester, Kentucky.
Cited most
Across all Catalent Pharma Solutions observations on file
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.194(a)(8)Laboratory records1
The complete Catalent Pharma Solutions file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Winchester, Kentucky
Two Form 483s · 2023 to 2025 · 5 observations
Latest: Form 483, Apr 22, 2025 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-04-22 | 483 Form 483 | Winchester, Kentucky | 4 | $99 |
| 2023-01-11 | 483 Form 483 | Winchester, Kentucky | 1 | $99 |
Investigators on these documents
Jeffrey T. Prosterman (1)Logan T. Williams (1)Paige R. McCoy (1)Stephenie M. Ortiz (1)Wen Ning Chan (1)
FEI number 1000122400 · most recent document Apr 22, 2025
About Catalent Pharma Solutions, LLC
How many FDA Form 483s has Catalent Pharma Solutions, LLC received?
FDA Intel has 2 Form 483s on file for Catalent Pharma Solutions, LLC; the most recent is dated Apr 22, 2025.
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 Apr 22, 2025, for the site in Winchester, Kentucky.
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 211.113 (Control of microbiological contamination), 1 time; 21 CFR 211.194(a)(8) (Laboratory records), 1 time.