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483
•Catalent Indiana, LLC

Catalent Indiana, LLC – FDA 483

Record Details

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.

Company
Catalent Indiana, LLC
Product type
biologics
Office
Division of Pharmaceutical Quality Operations III
People
  • Muna Algharibeh (Investigator)
  • Logan T. Williams (Investigator )
  • Sandra A. Boyd (Drug National Expert)
  • Eboni S. Funderburk
View Company Profile

ID · 70255023-0dba-4473-a659-64d38a7df3ea

Other documents for Catalent Indiana, LLC
  • 483 - 2026-04-24April 24, 2026
  • WARNING_LETTER - 2025-07-14July 14, 2025
  • 483 - 2025-06-23June 23, 2025
  • 483 - 2023-11-15November 15, 2023
  • 483 - 2023-05-12May 12, 2023

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