FDA 483 - Sentio Biosciences LLC - April 19, 2019

An FDA inspection of Sentio BioSciences LLC, a manufacturer in Maryland Heights, MO, revealed significant deficiencies in their quality systems. Observations included inadequate written procedures for equipment qualification, failure to follow established procedures for out-of-specification results and stability studies, and a lack of label specimens in batch manufacturing records. These issues indicate a need for improved control over manufacturing processes and documentation.