FDA 483 - S&B Pharma LLC - June 17, 2022

S and B Pharma LLC DBA Alkem Laboratories in Fenton, MO, was inspected and cited for significant deficiencies in equipment qualification, production and process controls, and in-process material testing. The inspection revealed issues with capsule filling equipment qualification, lack of established defect limits, and inadequate in-process sampling and testing procedures. These observations indicate a need for improved adherence to cGMP regulations to ensure drug product quality and purity.