FDA 483 - Excite Pharma Services, LLC - October 24, 2023

Excite Pharma Services, LLC, a manufacturer in Lees Summit, MO, was cited for significant deficiencies during an FDA inspection. Observations included failures in batch record investigations for discrepancies and deviations, lack of established and validated procedures for production and process controls, and inadequate laboratory controls for in-process material sampling and homogeneity testing. These issues indicate a lack of robust quality systems and control over manufacturing processes.