Catalent CTS, LLC
Form 483 issued March 23, 2026 · Kansas City, Missouri
- Inspection
- Mar 16 – Mar 23, 2026
- Investigator
- Kelly M. Bromley
- Observations
- 1
- Pages
- 3
- FEI number
- 3002929455
In short: On March 23, 2026, FDA issued a Form 483 with 1 observation to Catalent CTS, LLC in Kansas City, Missouri (FEI 3002929455) after an inspection that ran Mar 16 – Mar 23, 2026. The investigator was Kelly M. Bromley.
What FDA observed
Preview: the opening words of each observation- 01
Appropriate written procedures, designed to prevent objectionable microorganisms in drug products not required to be sterile…
This inspection in context
Kelly M. Bromley
4 documents · 2026
Cites 211.192 (production record review) 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.
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Questions about this 483
What did FDA find at Catalent CTS, LLC?
FDA listed 1 observation on this Form 483. The opening words of each observation are shown on this page.
Who inspected Catalent CTS, LLC?
Kelly M. Bromley is named on this Form 483, for the inspection of Mar 16 – Mar 23, 2026. Each investigator has a profile showing what they cite most.
When was Catalent CTS, LLC inspected by FDA?
The inspection ran Mar 16 – Mar 23, 2026, and the Form 483 is dated March 23, 2026.
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.