FDA 483 - Ipca Laboratories Limited - April 26, 2023

Ipca Laboratories Ltd. in Piparia, Silvassa, India, was cited for significant deficiencies in its quality control unit and laboratory operations during an FDA inspection. The firm failed to adequately investigate out-of-specification and out-of-trend results, often invalidating them without scientific justification, and demonstrated a lack of data integrity across various systems and documentation practices. Additionally, deviation investigations and corrective actions were found to be untimely, inaccurate, and ineffective.