FDA 483 - Supriya Lifescience Limited - October 03, 2019

An FDA inspection of Supriya Lifescience Ltd. in Ratnagiri, India, revealed seven significant observations regarding their API manufacturing processes. The firm demonstrated a lack of adequate cleaning and process validation, insufficient risk analysis, and poor quality unit oversight. Additionally, deficiencies were noted in equipment maintenance, record-keeping practices, and the storage of reserve and stability samples, indicating a need for comprehensive corrective actions.