FDA EIR - OSO Biopharmaceuticals Manufacturing LLC - March 15, 2019

An FDA Pre-Approval Inspection was conducted at OSO BioPharmaceuticals Manufacturing, LLC in Albuquerque, NM, from March 11 to March 15, 2019. This inspection, carried out under Compliance Program CP 7346.832, focused on the company's readiness for commercial manufacturing of a sterile drug product. Following the inspection, an eight-item Form FDA 483, Inspectional Observations, was issued. Key deficiencies identified included poor aseptic practices, inadequate qualification of mixing equipment, and non-representative drug product sampling. The inspection also highlighted issues with master batch production records lacking actual and theoretical yield statements, and incomplete manufacturing and control instructions. Furthermore, inadequate method validation studies, failure to detect and initiate investigations, and insufficient controls for computerized systems were observed. Management at OSO BioPharmaceuticals Manufacturing, LLC committed to providing a written response to the FDA within fifteen business days to address these observations and outline corrective actions.