FDA 483 - KRS PHARMACEUTICALS PRIVATE LIMITED - November 21, 2025

An FDA inspection of KRS Pharmaceuticals Private Limited [Unit-II] in Anakapalli, Andhra Pradesh, India, conducted from November 17-21, 2025, identified six significant observations. The Active Pharmaceutical Ingredient (API) manufacturer was cited for various deficiencies impacting product quality and regulatory compliance. Key findings included the failure to maintain API manufacturing equipment in a good state of repair, specifically a reaction vessel, affecting US market batches. Critical equipment, an FT-IR spectrometer used for API release testing, was found to be uncalibrated past its due date, compromising the integrity of released products. The firm's product impurity testing was deemed inadequate, lacking a complete risk assessment for solvents and not testing solvents for related impurities upon receipt. Process validation for recovered solvents lacked scientific rationale, focusing only on purity without comprehensive impurity testing. Furthermore, sampling procedures for in-process materials, finished products, and raw materials were insufficient to ensure representative samples. Finally, solvent suppliers were qualified without adequately establishing the reliability of their raw materials. KRS Pharmaceuticals is required to address these observations by developing and implementing comprehensive corrective and preventive actions to ensure compliance with current Good Manufacturing Practices (cGMP) regulations.