FDA 483 - Shilpa Pharma Lifesciences Limited - March 07, 2025

An FDA inspection of Shilpa Pharma Lifesciences Limited, an API non-sterile drug substance manufacturer in Deosugur, revealed significant deficiencies in their Quality Control unit. The firm repeatedly failed to ensure QC personnel followed approved testing procedures, leading to over one hundred human errors since January 2022. Corrective actions, including retraining, have proven ineffective in addressing these persistent issues.