FDA 483 - LSNE-Leon, SLU - September 19, 2023

LSNE-Leon, SLU, a sterile drug manufacturer in Leon, Spain, was cited for significant deficiencies during an FDA inspection. Observations included inadequate integrity testing of RABS equipment, scientifically unjustified invalidation of OOS results and a stability chamber excursion, poor quality unit oversight of production activities, and a deficient supplier qualification program for sterile APIs. These issues indicate a lack of robust quality control and aseptic process assurance.