Catalent Pharma Solutions, LLC
Form 483 issued April 22, 2025 · Winchester, Kentucky
- Inspection
- Mar 11, 2024 – Apr 22, 2025
- Investigators
- Jeffrey T. Prosterman· Paige R. McCoy· Stephenie M. Ortiz
- Observations
- 4
- Pages
- 26
- FEI number
- 1000122400
In short: On April 22, 2025, FDA issued a Form 483 with 4 observations to Catalent Pharma Solutions, LLC in Winchester, Kentucky (FEI 1000122400) after an inspection that ran Mar 11, 2024 – Apr 22, 2025. The investigators were Jeffrey T. Prosterman, Paige R. McCoy and Stephenie M. Ortiz. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
This inspection in context
Jeffrey T. Prosterman
5 documents · 2025–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Arizona.
The firmCatalent Pharma Solutions, LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Catalent Pharma Solutions, LLC?
FDA listed 4 observations on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Catalent Pharma Solutions, LLC?
Jeffrey T. Prosterman, Paige R. McCoy and Stephenie M. Ortiz are named on this Form 483, for the inspection of Mar 11, 2024 – Apr 22, 2025. Each investigator has a profile showing what they cite most.
When was Catalent Pharma Solutions, LLC inspected by FDA?
The inspection ran Mar 11, 2024 – Apr 22, 2025, and the Form 483 is dated April 22, 2025.
How do I get the full Form 483 for Catalent Pharma Solutions, 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.