FDA 483 - Sterinova Inc. - September 07, 2022

An FDA inspection of Sterinova Inc., a sterile drug product manufacturer in Saint-Hyacinthe, revealed significant deficiencies in aseptic processing. Observations included failures in sterile gowning procedures and personnel monitoring, as well as inadequate cleaning and disinfection processes within Restricted Access Barrier Systems (RABS). These issues indicate a lack of control over microbiological contamination and aseptic conditions.