Catalent Indiana, LLC
Form 483 issued September 1, 2022 · Bloomington, Indiana
- Inspection
- Aug 1 – Sep 1, 2022
- Investigators
- Eboni Funderburk· Logan T. Williams· Muna Algharibeh
- Observations
- 6
- Pages
- 18
In short: On September 1, 2022, FDA issued a Form 483 with 6 observations to Catalent Indiana, LLC in Bloomington, Indiana after an inspection that ran Aug 1 – Sep 1, 2022. The investigators were Eboni Funderburk, Logan T. Williams, Muna Algharibeh and Sandra A. Boyd. Most observations concern production and quality system.
At a glance
Production and quality system account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any…
- 03
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
- 05
Equipment used in the manufacturing of a drug product is not of appropriate design to facilitate…
- 06
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
This inspection in context
Eboni Funderburk
2 documents · 2021–2022
Cites 211.100(a) (written procedures; deviations) more than any other section. Most of their documents are for sites in Indiana.
The firmCatalent Indiana, LLC history
All 10 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Catalent Indiana, LLC?
FDA listed 6 observations on this Form 483, mostly about production, quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Catalent Indiana, LLC?
Eboni Funderburk, Logan T. Williams, Muna Algharibeh and Sandra A. Boyd are named on this Form 483, for the inspection of Aug 1 – Sep 1, 2022. Each investigator has a profile showing what they cite most.
When was Catalent Indiana, LLC inspected by FDA?
The inspection ran Aug 1 – Sep 1, 2022, and the Form 483 is dated September 1, 2022.
How do I get the full Form 483 for Catalent Indiana, 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.