FDA 483 - Shilpa Medicare Limited - November 21, 2025

An FDA inspection of Shilpa Medicare Limited in Polepally, India, revealed critical deficiencies in the manufacturing of sterile drug products. The firm failed to adequately validate aseptic and sterilization processes, maintain proper visual inspection programs, and ensure equipment cleanliness and maintenance. Significant issues were also noted in discrepancy investigations, data integrity, and the scientific soundness of laboratory controls and stability programs.