Catalent CTS, LLC
Form 483 issued November 10, 2014 · Kansas City, Missouri
- Inspection
- Oct 27 – Nov 10, 2014
- Investigator
- Victoria A. Wagoner
- Observations
- 4
- Pages
- 2
- FEI number
- 3002929455
In short: On November 10, 2014, FDA issued a Form 483 with 4 observations to Catalent CTS, LLC in Kansas City, Missouri (FEI 3002929455) after an inspection that ran Oct 27 – Nov 10, 2014. The investigator was Victoria A. Wagoner. Most observations concern production and laboratory controls.
At a glance
Production and laboratory controls 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
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 02
Control procedures are not established which monitor the output of those manufacturing processes that may be…
- 03
Master production and control records lack complete manufacturing and control instructions and…
- 04
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
Victoria A. Wagoner
1 document · 2014
Cites 211.110 (sampling and testing of in-process materials and drug products) more than any other section. Most of their documents are for sites in Missouri.
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 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Catalent CTS, LLC?
FDA listed 4 observations on this Form 483, mostly about production, laboratory controls and quality system. The opening words of each observation are shown on this page.
Who inspected Catalent CTS, LLC?
Victoria A. Wagoner is named on this Form 483, for the inspection of Oct 27 – Nov 10, 2014. Each investigator has a profile showing what they cite most.
When was Catalent CTS, LLC inspected by FDA?
The inspection ran Oct 27 – Nov 10, 2014, and the Form 483 is dated November 10, 2014.
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.