FDA EIR - Curia New Mexico, LLC - March 20, 2020

An FDA inspection of OSO BioPharmaceuticals Manufacturing, LLC (AMRI) in Albuquerque, NM, conducted from March 16-20, 2020, identified significant deficiencies in the company's adherence to current Good Manufacturing Practices (CGMP) for sterile drug manufacturing. The inspection, guided by regulatory frameworks including 21 CFR 211.113(b) and 21 CFR 211.192, resulted in two primary observations detailed in an FDA-483.The first observation concerned the inadequate establishment of procedures designed to prevent microbiological contamination of sterile drug products. Specific issues included improper operator goggle usage, operators reaching above shoulder height in aseptic areas potentially generating particles, a lack of validated contact times for glove sanitization, re-using wipes, insufficient environmental sampling of gloves, and non-hermetically sealed packaging for sterilized equipment parts. Additionally, viable monitoring plates were not ideally positioned to optimize detection of potential contamination.The second major issue was that written records of investigations into unexplained discrepancies were incomplete. This was exemplified by unverified corrective actions for recurring insect infestations in manufacturing areas and the failure to initiate investigations for visible particles found during the 100% visual inspection of sterile drugs. The report also noted that corrections from a prior 2019 inspection, which cited poor aseptic practices, were not verified.Management acknowledged these observations and committed to implementing necessary corrections and providing a written response to the FDA within 15 days, outlining their proposed actions and timelines.