FDA 483 - Sentio Biosciences LLC - February 06, 2024

An FDA inspection of Sentio Biosciences LLC in Maryland Heights, MO, revealed critical deficiencies in monitoring and controlling objectionable organisms within their (b)(4) system used for non-sterile API manufacturing. The firm's microbial test methods were not validated to detect Burkholderia cepacia complex, and a significant leak in the system went unaddressed for an extended period. These issues pose a high risk of microbial and chemical contamination to drug substances like Melarsomine Dihydrochloride and Pentosan Polysulfate Sodium.