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

During an inspection conducted from March 3-7, 2025, Shilpa Pharma Lifesciences Limited, an API Non-Sterile Drug Substance Manufacturer located in Deosugur, Raichur, Karnataka, received an FDA Form 483 outlining significant observations related to its quality control operations. The primary issue identified was the company's failure to ensure that its Quality Control (QC) laboratory personnel consistently adhere to approved testing procedures for finished products and raw materials. Specifically, the FDA observed a recurring pattern of "human errors" in the QC lab, with over one hundred such incidents reported since January 2022. These errors included critical mistakes like incorrect sample details in HPLC systems, missing peak names, improper instrument method names, and incorrect batch numbers. Despite the implementation of various corrective actions, including awareness training, retraining, and re-qualification of analysts, these fundamental procedural deviations have persisted, indicating the ineffectiveness of the current corrective measures. This points to a systemic breakdown in the firm's quality management system concerning employee adherence to established protocols. Shilpa Pharma Lifesciences Limited is now required to implement robust and effective corrective and preventive actions to address these serious quality control deficiencies and ensure full compliance with Good Manufacturing Practices, which are fundamental to the regulatory framework governing drug substance manufacturing.