FDA 483 - Catalent Pharma Solutions LLC - May 22, 2026
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Catalent Pharma Solutions LLC in Morrisville, NC, was inspected from May 18-22, 2026, and cited for deficiencies in their cleaning and maintenance procedures for drug manufacturing equipment. The firm failed to adequately evaluate the effectiveness of disinfectants against recovered environmental microbial isolates and did not follow its own procedures for performing disinfectant efficacy studies. This indicates a significant concern regarding the control of microbial contamination in their drug product manufacturing facility.
ID · 5e16c0dd-8d4f-4bb5-9e7d-01701e77a4b0