FDA EIR - Curia New Mexico, LLC - March 15, 2019

OSO BioPharmaceuticals Manufacturing, LLC, a contract manufacturer of sterile drug and biopharmaceutical products in Albuquerque, New Mexico, underwent an FDA Pre-Approval Inspection from March 11 to March 15, 2019. This inspection, conducted under Compliance Program 7346.832, focused on the firm's readiness for commercial manufacturing of a new drug application product. During the five-day audit, FDA investigators issued an eight-item Form FDA 483, highlighting several significant observations. Main issues included deficiencies in aseptic practices and inadequate qualification of mixing equipment, raising concerns about process reliability. Additionally, drug product samples were found not to be representative of entire batches, and master production records lacked complete manufacturing instructions and theoretical yield data at each step. The inspection also noted inadequate method validation studies, a failure to initiate investigations into deviations, and insufficient controls for computerized systems. In response, OSO BioPharmaceuticals Manufacturing's management committed to submitting a written reply to the FDA within fifteen business days, detailing their corrective and preventive actions to address these findings.