Catalent Indiana, LLC
Form 483 issued October 18, 2019 · Bloomington, Indiana
- Inspection
- Oct 7 – Oct 18, 2019
- Investigators
- Jon P. Antoniou· Michele Perry Williams· Vaishali J. Patel
- Observations
- 5
- Pages
- 5
- FEI number
- 3005949964
In short: On October 18, 2019, FDA issued a Form 483 with 5 observations to Catalent Indiana, LLC in Bloomington, Indiana (FEI 3005949964) after an inspection that ran Oct 7 – Oct 18, 2019. The investigators were Jon P. Antoniou, Michele Perry Williams and Vaishali J. Patel. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Production and facilities & equipment account for 4 of 5 observations.
Most cited: 21 CFR 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Storage of drug products under appropriate conditions of temperature, humidity, and light so that the identity…
- 02
Written production and process control procedures are not followed in the execution of production…
- 03
Procedure designed to prevent microbiological contamination of drug products purporting to be…
- 04
Equipment shall be cleaned and maintained at appropriate intervals to prevent contamination that would alter the…
This inspection in context
Jon P. Antoniou
4 documents · 2019–2021
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 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Catalent Indiana, LLC?
FDA listed 5 observations on this Form 483, mostly about production, facilities & equipment and materials. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Catalent Indiana, LLC?
Jon P. Antoniou, Michele Perry Williams and Vaishali J. Patel are named on this Form 483, for the inspection of Oct 7 – Oct 18, 2019. Each investigator has a profile showing what they cite most.
When was Catalent Indiana, LLC inspected by FDA?
The inspection ran Oct 7 – Oct 18, 2019, and the Form 483 is dated October 18, 2019.
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.