Catalent Pharma Solutions, LLC
Form 483 issued January 11, 2023 · Winchester, Kentucky
- Inspection
- Jan 4 – Jan 11, 2023
- Investigators
- Logan T. Williams· Wen Ning Chan
- Observations
- 1
- Pages
- 3
- FEI number
- 1000122400
In short: On January 11, 2023, FDA issued a Form 483 with 1 observation to Catalent Pharma Solutions, LLC in Winchester, Kentucky (FEI 1000122400) after an inspection that ran Jan 4 – Jan 11, 2023. The investigators were Logan T. Williams and Wen Ning Chan. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.194 (laboratory records).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.194(a)(8) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Laboratory records do not include the initials or signature of a second person showing that the…
This inspection in context
Logan T. Williams
32 documents · 2020–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Kentucky.
The firmCatalent Pharma Solutions, LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.194(a)(8)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Catalent Pharma Solutions, LLC?
FDA listed 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.194 (laboratory records). The opening words of each observation are shown on this page.
Who inspected Catalent Pharma Solutions, LLC?
Logan T. Williams and Wen Ning Chan are named on this Form 483, for the inspection of Jan 4 – Jan 11, 2023. Each investigator has a profile showing what they cite most.
When was Catalent Pharma Solutions, LLC inspected by FDA?
The inspection ran Jan 4 – Jan 11, 2023, and the Form 483 is dated January 11, 2023.
How do I get the full Form 483 for Catalent Pharma Solutions, 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.