S&B Pharma LLC – FDA 483, Nov 8, 2022

S and B Pharma, Inc. in Fenton, MO, a drug manufacturer, was cited for significant deficiencies during an FDA inspection. Observations included failures in thoroughly investigating out-of-specification results and production deviations, inadequate quality control unit procedures for data review and batch release, and a lack of established procedures for testing drug products for objectionable microorganisms like Burkholderia cepacia complex. These issues indicate a need for improved quality system oversight and microbial control.