FDA 483 - Sterling Pharmaceutical Services LLC - February 18, 2022

Sterling Pharmaceutical Services LLC, a sterile ophthalmic drug manufacturer in Dupo, IL, received a Form 483 with four observations. The inspection revealed significant deficiencies in aseptic processing validation, quality control unit procedures, investigation of discrepancies, and adherence to contamination prevention procedures. These issues indicate a systemic lack of control over sterile manufacturing processes.