FDA 483 - S and B Pharma LLC DBA Alkem Laboratories - June 17, 2022

An FDA inspection of S and B Pharma LLC DBA Alkem Laboratories in Fenton, MO, revealed significant deficiencies across multiple areas of drug manufacturing. Observations included inadequately designed and qualified capsule filling equipment, a lack of robust written procedures for production and process controls, and insufficient in-process material testing. These findings indicate a need for substantial corrective actions to ensure compliance with cGMP regulations and maintain drug product quality.