FDA 483 - Agon Pharma Private Ltd - January 31, 2025

Agon Pharma Private Ltd in Pune, Maharashtra, was cited with eight observations during an FDA inspection from January 27-31, 2025. The inspection revealed significant deficiencies in quality unit responsibilities, batch record documentation, laboratory controls, recording of quality activities, packaging material specifications, raw material sampling procedures, process monitoring, and equipment cleaning, with one repeat observation from a previous inspection. These issues indicate a systemic failure to comply with CGMP for Active Pharmaceutical Ingredients (APIs) intended for the US market.