FDA 483 - Intas Pharmaceuticals Ltd. - September 17, 2025

Intas Pharmaceuticals Limited in Dehradun, India, was inspected from September 8-17, 2025, and received a Form 483 with three observations. The inspection revealed significant issues including inadequate review of unexplained discrepancies, unsupported drug product shelf-life, and numerous out-of-specification results. Furthermore, the firm was cited for unauthorized modifications to electronic batch records without proper audit trails, and for incomplete batch production and control records.