FDA 483 - S&B Pharma LLC - February 06, 2020

An FDA inspection of S & B Pharma, Inc. dba Alkem Laboratories in Fenton, MO, a drug manufacturer, revealed significant deficiencies in quality control and record-keeping. Observations included inadequate investigation records and corrective actions, scientifically unsound laboratory sampling plans, and a failure to conduct required annual product reviews. These issues indicate a lack of adherence to good manufacturing practices.