FDA 483 - Sterling Pharmaceutical Services LLC - May 01, 2024

This FDA Form 483 details significant deficiencies at Sterling Pharmaceutical Services LLC, a sterile ophthalmic manufacturer in Dupo, IL. The firm repeatedly failed to thoroughly investigate microbial contamination, including Bacillus cereus, and released commercial lots without definitive root cause analysis or adequate aseptic process simulations. Other critical issues include inadequate environmental monitoring, cleaning/disinfection validation, equipment maintenance, and control procedures for water systems and analytical methods, indicating a systemic lack of control over sterile manufacturing processes.