FDA 483 - Sterling Pharmaceutical Services LLC - May 14, 2021

Sterling Pharmaceutical Services, LLC, a sterile ophthalmic drug manufacturer in Dupo, IL, was cited for significant deficiencies across its aseptic processing, environmental monitoring, investigation practices, and quality control unit. The inspection revealed issues with preventing microbiological contamination, inadequate environmental controls, and insufficient investigations into critical deviations and out-of-specification results. These findings indicate a systemic breakdown in maintaining a state of control for sterile drug manufacturing.