Catalent Indiana, LLC
Form 483 issued May 12, 2023 · Bloomington, Indiana
- Inspection
- May 12, 2023
- Investigators
- Esther C. Broner· Hyung-Yul Lee· Wayne Seifert
- Observations
- 3
- Pages
- 4
- FEI number
- 3005949964
In short: On May 12, 2023, FDA issued a Form 483 with 3 observations to Catalent Indiana, LLC in Bloomington, Indiana (FEI 3005949964) after an inspection that ran May 12, 2023. The investigators were Esther C. Broner, Hyung-Yul Lee and Wayne Seifert. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
2 of 3 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (2×)
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…
- 02
Equipment revalidation in support of…
- 03
Equipment and facilities are not adequately maintained or cleaned…
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
All 10 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
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 and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). 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 May 12, 2023. Each investigator has a profile showing what they cite most.
When was Catalent Indiana, LLC inspected by FDA?
The inspection ran May 12, 2023, and the Form 483 is dated May 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.