FDA 483 - S&B Pharma LLC - September 14, 2022

S and B Pharma LLC DBA Alkem Laboratories, a human drug manufacturer in Fenton, MO, was cited for two observations during an FDA inspection. The firm failed to establish and follow written procedures for in-process controls, including blend uniformity testing and consistent blend assay methods. Additionally, procedures to prevent objectionable microorganisms in non-sterile drug products were not established or followed, evidenced by a water system leak.