FDA 483 - Ritsa Pharma Private Limited - September 05, 2025

An FDA inspection of Ritsa Pharma Private Limited in Medchal Malkajgiri, India, revealed deficiencies in their materials system. The firm failed to establish the reliability of component suppliers and did not conduct appropriate testing to ensure the quality, purity, and strength of received components. This included not validating supplier COAs and inadequate material sampling methods.