Catalent Pharma Solutions LLC
Form 483 issued May 24, 2024 · Morrisville, North Carolina
- Inspection
- May 21 – May 24, 2024
- Investigators
- Richard L. Bartlett· Travis S. Bradley
- Observations
- 1
- Pages
- 3
- FEI number
- 1000110912
In short: On May 24, 2024, FDA issued a Form 483 with 1 observation to Catalent Pharma Solutions LLC in Morrisville, North Carolina (FEI 1000110912) after an inspection that ran May 21 – May 24, 2024. The investigators were Richard L. Bartlett and Travis S. Bradley. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.67(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the…
This inspection in context
Richard L. Bartlett
4 documents · 2024–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmCatalent Pharma Solutions LLC history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67(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 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Catalent Pharma Solutions LLC?
Richard L. Bartlett and Travis S. Bradley are named on this Form 483, for the inspection of May 21 – May 24, 2024. Each investigator has a profile showing what they cite most.
When was Catalent Pharma Solutions LLC inspected by FDA?
The inspection ran May 21 – May 24, 2024, and the Form 483 is dated May 24, 2024.
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.