FDA 483 - Catalent Indiana, LLC

This document is a response from Catalent Indiana, LLC in Bloomington, Indiana, to a Form FDA 483 issued following an inspection conducted from August 1 to September 1, 2022. The firm expresses its commitment to full compliance with 21 CFR Part 211 and other relevant regulations, aiming to ensure drug product quality and safety. Specific inspectional observations are not detailed in this response.