FDA 483 - Apitoria Pharma Private Limited - November 18, 2022

Aurobindo Pharma Limited Unit IX, an Active Pharmaceutical Ingredient Intermediate manufacturer, underwent an FDA inspection from November 10 to November 18, 2022. The inspection identified critical deficiencies in the company's quality control systems, specifically regarding Out of Specification (OOS) and market complaint investigations.

The main issue cited was that investigations into OOS results and customer complaints for API intermediate products were frequently not scientifically sound or comprehensive enough to accurately determine root causes. Examples included an OOS investigation for impurity failure during stability testing that attributed the problem to a specification revision, despite evidence of persistent failures, and a corrective action plan containing inaccurate statements about batch compliance. Similarly, multiple market complaints regarding elevated impurity levels in products manufactured using re-processed materials led to investigations whose conclusions contradicted previous OOS findings, with inconsistent supporting data for proposed root causes. Other instances showed OOS investigations prematurely invalidating results based on unsubstantiated causes or attributing failures to process variations without adequate evidence, indicating a pervasive systemic weakness in the firm's investigative processes.

These findings signify non-compliance with Current Good Manufacturing Practices (cGMP) regulations, which mandate rigorous quality systems in pharmaceutical manufacturing. Aurobindo Pharma Limited Unit IX is expected to thoroughly address these observations by implementing comprehensive corrective and preventive actions to ensure the scientific integrity and completeness of their investigations, thereby safeguarding product quality and achieving regulatory compliance.