FDA 483 - Steriscience Specialties Private Limited - December 20, 2019

Mylan Laboratories Limited (Sterile Products Division) in Bangalore, India, received a Form 483 for failing to thoroughly review unexplained discrepancies. The firm's investigation into product discoloration and improper vial stoppers, which led to product recalls, was not adequately extended to other sterile and liquid drug products manufactured using the same detection system. This indicates a significant deficiency in their quality system for discrepancy management and product control.