FDA 483 - Laboratorios Farmalan, S.A. - March 19, 2019

Laboratorios Farmalan, S.A. in Leon, Spain, a sterile drug manufacturer, received a Form FDA 483 with five observations. The inspection revealed significant deficiencies in investigation procedures for discrepancies and OOS results, inadequate laboratory controls, and poor environmental monitoring in aseptic processing areas. Additionally, issues were noted with equipment control for microorganisms and humidity, and a lack of established control procedures for manufacturing process validation.