Catalent Indiana, LLC
Form 483 issued August 12, 2023 · Bloomington, Indiana
- Inspection
- Aug 12, 2023
- Investigators
- Esther C. Broner· Hyung-Yul Lee· Wayne Seifert
- Observations
- 3
- Pages
- 4
- FEI number
- 3005949954
In short: On August 12, 2023, FDA issued a Form 483 with 3 observations to Catalent Indiana, LLC in Bloomington, Indiana (FEI 3005949954) after an inspection that ran Aug 12, 2023. The investigators were Esther C. Broner, Hyung-Yul Lee and Wayne Seifert. Most observations concern production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.100 (1×) · 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
Written production and process control procedures are not followed or established in the execution of production…
This inspection in context
Esther C. Broner
4 documents · 2022–2024
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Indiana.
The firmCatalent Indiana, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Catalent Indiana, LLC?
FDA listed 3 observations on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Catalent Indiana, LLC?
Esther C. Broner, Hyung-Yul Lee and Wayne Seifert are named on this Form 483, for the inspection of Aug 12, 2023. Each investigator has a profile showing what they cite most.
When was Catalent Indiana, LLC inspected by FDA?
The inspection ran Aug 12, 2023, and the Form 483 is dated August 12, 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.