FDA 483 - Steriscience Specialties Private Limited - November 22, 2024

An FDA inspection of Steriscience Specialties Private Limited, a sterile drug manufacturer in Bengaluru, revealed significant deficiencies in their quality systems. Observations included inadequate validation of aseptic processes, lack of appropriate controls over computer systems to ensure data integrity, and failures in their change management procedures for written protocols. These issues suggest a potential risk to the sterility and quality of their drug products.