Catalent Indiana, LLC
Form 483 issued November 15, 2023 · Bloomington, Indiana
- Inspection
- Oct 31 – Nov 15, 2023
- Investigators
- Alan L. Truong· Jacob G. Lutz· Rafeeq Habeeb
- Observations
- 6
- Pages
- 10
- FEI number
- 3005949964
In short: On November 15, 2023, FDA issued a Form 483 with 6 observations to Catalent Indiana, LLC in Bloomington, Indiana (FEI 3005949964) after an inspection that ran Oct 31 – Nov 15, 2023. The investigators were Alan L. Truong, Jacob G. Lutz, Rafeeq Habeeb, Wendy G. Tan and Yuan-Chia Kuo. Most observations concern quality system and production.
At a glance
Quality system and production account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 04
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
This inspection in context
Alan L. Truong
16 documents · 2019–2025
Cites 211.188 (batch production and control records) more than any other section. Most of their documents are for sites in California.
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 211.22
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 quality system, production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Catalent Indiana, LLC?
Alan L. Truong, Jacob G. Lutz, Rafeeq Habeeb, Wendy G. Tan and Yuan-Chia Kuo are named on this Form 483, for the inspection of Oct 31 – Nov 15, 2023. Each investigator has a profile showing what they cite most.
When was Catalent Indiana, LLC inspected by FDA?
The inspection ran Oct 31 – Nov 15, 2023, and the Form 483 is dated November 15, 2023.
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.