Osmotica Pharmaceutical US LLC – FDA 483, May 2, 2025

An FDA inspection of Osmotica Pharmaceutical US LLC revealed significant deficiencies in their manufacturing operations. Findings included inadequate process validation for Methylphenidate HCL ER Tablets, deficient investigations into deviations and complaints, and a failure to follow established written procedures for production, quality control, and complaint handling. The observations highlight a need for improved quality system oversight and employee training to ensure drug product quality and compliance.