Catalent Pharma Solutions, LLC
Form 483 issued February 22, 2019 · St Petersburg, Florida
- Inspection
- Feb 11 – Feb 22, 2019
- Investigator
- Jessica L. Pressley
- Observations
- 3
- Pages
- 4
- FEI number
- 1811396
In short: On February 22, 2019, FDA issued a Form 483 with 3 observations to Catalent Pharma Solutions, LLC in St Petersburg, Florida (FEI 1811396) after an inspection that ran Feb 11 – Feb 22, 2019. The investigator was Jessica L. Pressley. Most observations concern laboratory controls and production.
At a glance
2 of 3 observations on this 483 concern laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
The written stability testing…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 03
Written production and process control procedures are not followed in the execution of production and. process…
This inspection in context
Jessica L. Pressley
24 documents · 2014–2021
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Florida.
The firmCatalent Pharma Solutions, LLC history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.166(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Catalent Pharma Solutions, LLC?
FDA listed 3 observations on this Form 483, mostly about laboratory controls and production. The opening words of each observation are shown on this page.
Who inspected Catalent Pharma Solutions, LLC?
Jessica L. Pressley is named on this Form 483, for the inspection of Feb 11 – Feb 22, 2019. Each investigator has a profile showing what they cite most.
When was Catalent Pharma Solutions, LLC inspected by FDA?
The inspection ran Feb 11 – Feb 22, 2019, and the Form 483 is dated February 22, 2019.
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.