Catalent Pharma Solutions LLC
Form 483 issued March 4, 2019 · Morrisville, North Carolina
- Inspection
- Feb 25 – Mar 4, 2019
- Investigator
- Sonya M. Edmonds
- Observations
- 4
- Pages
- 5
- FEI number
- 1000110912
In short: On March 4, 2019, FDA issued a Form 483 with 4 observations to Catalent Pharma Solutions LLC in Morrisville, North Carolina (FEI 1000110912) after an inspection that ran Feb 25 – Mar 4, 2019. The investigator was Sonya M. Edmonds. Most observations concern production and quality system.
At a glance
Observations span 3 systems, led by production.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are…
- 02
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 03
Written records of investigations into unexplained discrepancies do not always include…
- 04
Routine inspection of mechanical equipment is not performed according to a written program designed…
This inspection in context
Sonya M. Edmonds
12 documents · 2016–2025
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in North Carolina.
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 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Catalent Pharma Solutions LLC?
FDA listed 4 observations on this Form 483, mostly about production, quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Catalent Pharma Solutions LLC?
Sonya M. Edmonds is named on this Form 483, for the inspection of Feb 25 – Mar 4, 2019. Each investigator has a profile showing what they cite most.
When was Catalent Pharma Solutions LLC inspected by FDA?
The inspection ran Feb 25 – Mar 4, 2019, and the Form 483 is dated March 4, 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.