Catalent Indiana, LLC
Form 483 issued May 19, 2017 · Bloomington, Indiana
- Inspection
- May 15 – May 19, 2017
- Investigator
- Sargum C. Sood
- Observations
- 6
- Pages
- 6
- FEI number
- 3005949964
In short: On May 19, 2017, FDA issued a Form 483 with 6 observations to Catalent Indiana, LLC in Bloomington, Indiana (FEI 3005949964) after an inspection that ran May 15 – May 19, 2017. The investigator was Sargum C. Sood. Most observations concern production & process controls and quality system.
At a glance
Production & process controls and quality system account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Written production and process control procedures are not followed in the execution of production…
- 03
Process control procedures that describe any process controls necessary to ensure conformance to specifications have…
- 04
A process whose results cannot be fully verified by subsequent inspection and test has not been…
This inspection in context
Sargum C. Sood
5 documents · 2015–2017
Cites 820.30(d) (design controls) 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 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Catalent Indiana, LLC?
FDA listed 6 observations on this Form 483, mostly about production & process controls, quality system and production. The opening words of each observation are shown on this page.
Who inspected Catalent Indiana, LLC?
Sargum C. Sood is named on this Form 483, for the inspection of May 15 – May 19, 2017. Each investigator has a profile showing what they cite most.
When was Catalent Indiana, LLC inspected by FDA?
The inspection ran May 15 – May 19, 2017, and the Form 483 is dated May 19, 2017.
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.