Catalent Indiana, LLC
Form 483 issued September 2, 2020 · Bloomington, Indiana
- Inspection
- Aug 27 – Sep 2, 2020
- Investigator
- Michael R. Shanks
- Observations
- 1
- Pages
- 1
- FEI number
- 3005949964
In short: On September 2, 2020, FDA issued a Form 483 with 1 observation to Catalent Indiana, LLC in Bloomington, Indiana (FEI 3005949964) after an inspection that ran Aug 27 – Sep 2, 2020. The investigator was Michael R. Shanks. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 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
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
This inspection in context
Michael R. Shanks
27 documents · 2017–2024
Cites 211.113 (control of microbiological contamination) 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 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Catalent Indiana, LLC?
FDA listed 1 observation on this Form 483, mostly about production. 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?
Michael R. Shanks is named on this Form 483, for the inspection of Aug 27 – Sep 2, 2020. Each investigator has a profile showing what they cite most.
When was Catalent Indiana, LLC inspected by FDA?
The inspection ran Aug 27 – Sep 2, 2020, and the Form 483 is dated September 2, 2020.
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.