483
Virupaksha Organics LimitedFDA 483 - Virupaksha Organics Limited - February 03, 2025
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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.
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