FDA 483 - Supriya Lifescience Limited - February 06, 2026
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · f8990dae-dd91-4e78-a752-c690c171356d