S&B Pharma LLC – FDA 483, Jun 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.
ID · 3f2bce60-dc5e-4393-a563-4b89149f6f9c
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.