FDA 483 - Smilax Laboratories Limited - September 11, 2023

An FDA inspection of Smilax Laboratories Limited in Parawada-Vishakapatnam, India, an Active Pharmaceutical Ingredient Manufacturer, revealed a significant issue with the firm's investigation and corrective and preventive action management. The firm failed to follow its own SOP, specifically by not extending investigations to other potentially affected batches and products following complaints of foreign particles and dead insects.