Catalent Indiana, LLC
Form 483 issued May 1, 2018 · Bloomington, Indiana
- Inspection
- Apr 23 – May 1, 2018
- Investigators
- Cristina Ausin-Moreno· Nicholas L. Paulin· Scott R. Nichols
- Observations
- 4
- Pages
- 2
- FEI number
- 3005949964
In short: On May 1, 2018, FDA issued a Form 483 with 4 observations to Catalent Indiana, LLC in Bloomington, Indiana (FEI 3005949964) after an inspection that ran Apr 23 – May 1, 2018. The investigators were Cristina Ausin-Moreno, Nicholas L. Paulin, Scott R. Nichols and Yanming An. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is an unacceptably high number of mold recoveries in the classified rooms used for manufacture…
- 02
Written procedures to prevent contamination of drug…
- 03
There is a lack of quality oversight in the review of records and procedures followed…
- 04
Corrective actions do not include implementation of adequate procedures to prevent…
This inspection in context
Cristina Ausin-Moreno
1 document · 2018
Cites 211.100 (written procedures; deviations) 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 211.46
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Catalent Indiana, LLC?
FDA listed 4 observations on this Form 483, mostly about quality system, facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected Catalent Indiana, LLC?
Cristina Ausin-Moreno, Nicholas L. Paulin, Scott R. Nichols and Yanming An are named on this Form 483, for the inspection of Apr 23 – May 1, 2018. Each investigator has a profile showing what they cite most.
When was Catalent Indiana, LLC inspected by FDA?
The inspection ran Apr 23 – May 1, 2018, and the Form 483 is dated May 1, 2018.
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.