FDA 483 - Shilpa Medicare Limited - November 21, 2025

Shilpa Medicare Limited received a Form 483 detailing significant deficiencies in their sterile drug product manufacturing. The observations highlight inadequate validation of aseptic and sterilization processes, a deficient visual inspection program, and poor cleaning and maintenance of aseptic processing areas. The firm also failed to thoroughly investigate discrepancies, maintain equipment, and establish scientifically sound laboratory controls and stability programs.