Catalent CTS, LLC
Form 483 issued October 23, 2018 · Kansas City, Missouri
- Inspection
- Oct 15 – Oct 23, 2018
- Investigator
- Wayne D. McGrath
- Observations
- 3
- Pages
- 3
- FEI number
- 3002929455
In short: On October 23, 2018, FDA issued a Form 483 with 3 observations to Catalent CTS, LLC in Kansas City, Missouri (FEI 3002929455) after an inspection that ran Oct 15 – Oct 23, 2018. The investigator was Wayne D. McGrath. Most observations concern facilities & equipment and quality system.
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 03
The flow of in-process materials through the building is not…
This inspection in context
Wayne D. McGrath
33 documents · 2018–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmCatalent CTS, LLC history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Catalent CTS, LLC?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and quality system. The opening words of each observation are shown on this page.
Who inspected Catalent CTS, LLC?
Wayne D. McGrath is named on this Form 483, for the inspection of Oct 15 – Oct 23, 2018. Each investigator has a profile showing what they cite most.
When was Catalent CTS, LLC inspected by FDA?
The inspection ran Oct 15 – Oct 23, 2018, and the Form 483 is dated October 23, 2018.
How do I get the full Form 483 for Catalent CTS, 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.