FDA 483 - Virupaksha Organics Limited - February 03, 2025

An FDA inspection of Virupaksha Organics Limited, Unit-I in Sangareddy, India, identified a significant labeling deficiency. The firm shipped active pharmaceutical ingredients (API) to the US without the required Caution Statement and Rx special legal requirement on the finished product labels. This indicates a serious non-compliance with labeling regulations for pharmaceutical products.