FDA 483 - Catalent Pharma Solutions, LLC - June 14, 2018

An FDA inspection of Catalent Pharma Solutions, LLC in Saint Petersburg, FL, an OTC and prescription drug gel capsule manufacturer, revealed significant deficiencies across production and quality control systems. Observations included failures in preventing microbial contamination, inadequate in-process material inspection, and insufficient review of production and control records. The report also highlighted inconsistent record-keeping and a repeat observation regarding equipment cleaning procedures, indicating a pattern of non-compliance.