FDA 483 - Nephron Sc Inc - April 20, 2022

Nephron Sc Inc, a drug manufacturer in West Columbia, SC, was cited for significant deficiencies during an FDA inspection. The observations include failures to thoroughly investigate unexplained discrepancies, inadequate laboratory controls for sterility testing, and deficiencies in environmental monitoring within aseptic processing areas. These issues indicate a lack of robust quality control and assurance processes.