Shilpa Pharma Lifesciences Limited, a wholly owned subsidiary of Shilpa Medicare Limited, successfully completed a United States Food and Drug Administration (USFDA) inspection at its Unit-1 facility in Raichur. The inspection was conducted from March 3-7, 2025.
At the conclusion of the inspection, the company received a single observation in Form 483, which is procedural in nature. Shilpa Pharma Lifesciences is actively working with the USFDA to address this observation within the stipulated timeframe.
In the exchange filing, Shilpa Medicare shared, “This is to inform you that United States Food and Drugs Administration (USFDA) has conducted an inspection at Unit-1 of Shilpa Pharma Lifesciences Limited, located at Raichur from March 3-7, 2025. On conclusion of inspection, we received 1 (one) observation in form 483, which is procedural in nature.”
Committed to maintaining the highest quality and regulatory standards, the company ensures strict compliance with global pharmaceutical guidelines. This latest USFDA inspection underscores Shilpa Pharma’s dedication to operational excellence and regulatory adherence.
