FDA 483 - Supriya Lifescience Limited - February 06, 2026

During an FDA inspection from February 2-6, 2026, Supriya Lifescience LTD. in Ratnagiri, India, was cited for failing to demonstrate that its manufacturing process can reproducibly produce intermediates and APIs meeting predetermined quality attributes. This critical issue is highlighted by multiple reprocessed batches and open Out of Specification investigations due to increased impurity levels, indicating significant concerns with process validation and product quality.