FDA 483 - S & B Pharma LLC - August 22, 2019

S and B Pharma, Inc. dba Alkem Laboratories in Fenton, MO, a drug manufacturer, was cited with four observations during an FDA inspection. The inspection revealed significant deficiencies in warehousing procedures, documentation practices for production and process controls, complaint handling, and facility maintenance. These issues indicate a lack of adherence to established procedures and good manufacturing practices.