FDA 483 - SOCIETAL CDMO SAN DIEGO, LLC - January 25, 2023

SOCIETAL CDMO SAN DIEGO, LLC, a Contract Development and Manufacturing Organization, received three observations during an FDA inspection. The firm failed to thoroughly review unexplained discrepancies for distributed drug product batches and did not fully adhere to quality control unit procedures, including timely CAPA reviews and complete sample tracking. Additionally, the manufacturing facility's construction was deemed unsuitable due to a ceiling hole and unaddressed environmental excursions in a critical production room.