FDA 483 - S&B Pharma LLC - June 18, 2021

An FDA inspection of S & B Pharma, Inc. dba Alkem Laboratories in Fenton, MO, a human drug manufacturer, revealed significant deficiencies in equipment design and qualification, as well as the quality control unit's procedures. The firm failed to ensure manufacturing equipment was in a qualified state and lacked proper documentation and scientific justification for critical quality attributes and testing. These findings indicate serious concerns regarding the firm's adherence to good manufacturing practices for drug products.